1. NAME OF THE MEDICINAL PRODUCT

Alendronic Acid Tablets USP 70mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:
Aldronate Sodium USP equivalent to
Alendronic Acid                                    70mg
Excipients                                                q.s.
For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Tablet.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of postmenopausal osteoporosis. Alendronic Acid reduces the risk of vertebral and hip fractures.

4.2 Posology and method of administration

Posology

The recommended dosage is one 70mg tablet once weekly.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Alendronic Acid on an individual patient basis, particularly after 5 or more years of use.

Special populations

Elderly patients:

In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. Therefore, no dosage adjustment is necessary for elderly people.

Paediatric population:

The safety and efficacy of alendronic acid in children less than18 years of age has not been established. This medicinal product should not be used in children less than 18 years of age. Currently available data for alendronic acid in the paediatric population is described in section 5.1.

Patients with renal impairment:

No dosage adjustment is necessary for patients with creatinine clearance greater than 35 ml/min. Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.

Method of administration

For oral administration.

To permit adequate absorption of Alendronic Acid.

Alendronic Acid must be taken at least 30 minutes before the first food, beverage, or medicinal product of the day with plain water only. Other beverages (including mineral water), food and some medicinal products are likely to reduce the absorption of alendronate (see section 4.5).

To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences (see section 4.4):

  • Alendronic Acid should only be swallowed upon arising for the day with a full glass of water (not less than 200 ml).
  • Patients should swallow Alendronic Acid whole. Patients should not crush or chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
  • Patients should not lie down until after their first food of the day which should be at least 30 minutes after taking the tablet.
  • Patients should not lie down for at least 30 minutes after taking Alendronic Acid
  • Alendronic Acid should not be taken at bedtime or before arising for the day.

Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate (see section 4.4).

Alendronic Acid has not been investigated in the treatment of glucocorticoid-induced osteoporosis.

4.3 Contraindications

Abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achalasia.

Inability to stand or sit upright for at least 30 minutes.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypocalcaemia (see also section 4.4).

4.4 Special warnings and precautions for use

Upper gastrointestinal adverse reactions

Alendronate can cause local irritation of the upper gastrointestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastrointestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastrointestinal bleeding, or surgery of the upper gastro-intestinal tract other than pyloroplasty (see section 4.3). In patients with known Barrett’s oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.

Oesophageal reactions (sometimes severe and requiring hospitalisation), such as oesophagitis, oesophageal ulcers and oesophageal erosions, rarely followed by oesophageal stricture, have been reported in patients receiving alendronate. Physicians should therefore be alert to any signs or symptoms signalling a possible oesophageal reaction and patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing or retrosternal pain, new or worsening heartburn.

The risk of severe oesophageal adverse experiences appears to be greater in patients who fail to take alendronate properly and/or who continue to take alendronate after developing symptoms suggestive of oesophageal irritation. It is very important that the full dosing instructions are provided to and understood by the patient (see section 4.2). Patients should be informed that failure to follow these instructions may increase their risk of oesophageal problems.

While no increased risk was observed in extensive clinical trials, there have been rare (post-marketing) reports of gastric and duodenal ulcers, some severe and with complications (see section 4.8).

Osteonecrosis of the jaw

Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelitis) has been reported in patients with cancer who are receiving treatment regimens including primarily intravenously administered bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.

The following risk factors should be considered when evaluating an individual’s risk of developing osteonecrosis of the jaw:

  • potency of the bisphosphonate (highest for zoledronic acid), route of administration (see above) and cumulative dose
  • cancer, chemotherapy, radiotherapy, corticosteroids, angiogenesis inhibitors, smoking
  • a history of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures and poorly fitting dentures.

A dental examination with appropriate preventive dentistry should be considered prior to treatment with oral bisphosphonates in patients with poor dental status.

While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

During bisphosphonate treatment, all patients should be encouraged to maintain good oral hygiene, receive routine dental check-ups, and report any oral symptoms such as dental mobility, pain, or swelling.

Osteonecrosis of the external auditory canal

Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms such as pain or discharge, or chronic ear infections.

Musculoskeletal pain

Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates. In post-marketing experience, these symptoms have rarely been severe and/or incapacitating (see section 4.8). The time to onset of symptoms varied from one day to several months after starting treatment. Most patients had relief of symptoms after stopping treatment. A subset had recurrence of symptoms when rechallenged with the same medicinal product or another bisphosphonate.

Atypical fractures of the femur

Atypical subtrochanteric and diaphyseal femoral fractures have been reported with bisphosphonate therapy, primarily in patients receiving long-term treatment for osteoporosis. These transverse or short oblique, fractures can occur anywhere along the femur from just below the lesser trochanter to just above the supracondylar flare. These fractures occur after minimal or no trauma and some patients experience thigh or groin pain, often associated with imaging features of stress fractures, weeks to months before presenting with a complete femoral fracture. Fractures are often bilateral; therefore, the contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Poor healing of these fractures has also been reported. Discontinuation of bisphosphonate therapy in patients suspected to have an atypical femur fracture should be considered pending evaluation of the patient, based on an individual benefit risk assessment.

During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture.

Skin reactions

In post-marketing experience, there have been rare reports of severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Missed dose

Patients should be instructed that if they miss a dose of alendronate, they should take one tablet on the morning after they remember. They should not take two tablets on the same day but should return to taking one tablet per week, as originally scheduled on their chosen day.

Renal impairment

Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, (see section 4.2).

Bone and mineral metabolism

Causes of osteoporosis other than oestrogen deficiency and ageing should be considered.

Hypocalcaemia must be corrected before initiating therapy with alendronate (see section 4.3). Other disorders affecting mineral metabolism (such as vitamin D deficiency and hypoparathyroidism) should also be effectively treated before starting this medicinal product. In patients with these conditions, serum calcium and symptoms of hypocalcaemia should be monitored during therapy with alendronate.

Due to the positive effects of alendronate in increasing bone mineral, decreases in serum calcium and phosphate may occur especially in patients taking glucocorticoids in whom calcium absorption may be decreased. These are usually small and asymptomatic. However, there have been rare reports of symptomatic hypocalcaemia, which have occasionally been severe and often occurred in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency and calcium malabsorption).

Ensuring adequate calcium and vitamin D intake is particularly important in patients receiving glucocorticoids.

Excipients

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronate. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product (see sections 4.2 and 5.2).

No other drug interactions with medicinal products of clinical significance are anticipated. A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronate. No adverse experiences attributable to their concomitant use were identified.

Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.

Although specific interaction studies were not performed, in clinical studies alendronate was used concomitantly with a wide range of commonly prescribed medicinal products without evidence of clinical adverse interactions.

4.6 Fertility, pregnancy and lactation

Pregnancy

Alendronate should not be used during pregnancy. There are no or limited amount of data from the use of alendronate in pregnant women. Studies in animals have shown reproductive toxicity. Alendronate given during pregnancy in rats caused dystocia related to hypocalcaemia (see section 5.3).

Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use (see section 5.2). There are no data on foetal risk in humans. However, there is a theoretical risk of foetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. The impact of variables such as time between cessation of bisphosphonate therapy to conception, the particular bisphosphonate used, and the route of administration (intravenous versus oral) on the risk has not been studied.

Breast-feeding

It is not known whether alendronate/metabolites are excreted into human breast milk. A risk to the newborns /infants cannot be excluded. Alendronate should not be used by breast-feeding women.

4.7 Effects on ability to drive and use machines

Alendronate has no or negligible direct influence on the ability to drive and use machines. However, certain adverse reactions (for example blurred vision, dizziness and severe bone, muscle or joint pain) that have been reported with alendronate may affect some patients’ ability to drive or operate machinery. Individual responses to alendronate may vary (see section 4.8).

4.8 Undesirable effects

Summary of the safety profile

In a one-year study in postmenopausal women with osteoporosis the overall safety profiles of alendronate sodium once weekly 70mg (n=519) and alendronate 10 mg/day (n=370) were similar.

In two three-year studies of virtually identical design, in postmenopausal women (alendronate 10 mg: n=196, placebo: n=397) the overall safety profiles of alendronate 10 mg/day and placebo were similar.

Adverse experiences reported by the investigators as possibly, probably or definitely drug-related are presented below if they occurred in ≥1% in either treatment group in the one-year study, or in ≥1% of patients treated with alendronate 10 mg/day and at a greater incidence than in patients given placebo in the three-year studies:

One-Year StudyThree-Year Studies
alendronate sodium

once weekly 70mg

(n=519)

%

alendronate

10 mg/day

(n=370)

%

alendronate

10 mg/day

(n=196)

%

Placebo

 

(n=397)

%

Gastro-intestinal
abdominal pain3.73.06.64.8
dyspepsia2.72.23.63.5
acid regurgitation1.92.42.04.3
nausea1.92.43.64.0
abdominal distension1.01.41.00.8
constipation0.81.63.11.8
diarrhoea0.60.53.11.8
dysphagia0.40.51.00.0
flatulence0.41.62.60.5
gastritis0.21.10.51.3
gastric ulcer0.01.10.00.0
oesophageal ulcer0.00.01.50.0
Musculoskeletal
musculoskeletal (bone, muscle or joint) pain2.93.24.12.5
muscle cramp0.21.10.01.0
Neurological
headache0.40.32.61.5

Tabulated list of adverse reactions

The following adverse experiences have also been reported during clinical studies and/or post-marketing use:

Frequencies are defined as: [Very common (≥1/10), Common (≥1/100 to < 1/10), Uncommon (≥1/1,000 to < 1/100), Rare (≥1/10,000 to < 1/1,000), Very rare (< 1/10,000)]

System Organ ClassFrequencyAdverse Experience Term
Immune system disorders:Rarehypersensitivity reactions including urticaria and angioedema
Metabolism and nutrition disorders:Raresymptomatic hypocalcaemia, often in association with predisposing conditions §
Nervous system disorders:Commonheadache, dizziness
Uncommondysgeusia
Eye disorders:Uncommoneye inflammation (uveitis, scleritis, episcleritis
Ear and labyrinth disorders:Commonvertigo
Gastrointestinal disorders:Commonabdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer*, dysphagia*, abdominal distension, acid regurgitation
Uncommonnausea, vomiting, gastritis, oesophagitis*, oesophageal erosions*, melaena
Rareoesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUBs (perforation, ulcers, bleeding) §
Skin and subcutaneous tissue disorders:Commonalopecia, pruritus
Uncommonrash, erythema
Rarerash with photosensitivity, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
Musculoskeletal and connective tissue disorders:Very commonmusculoskeletal (bone, muscle or joint) pain which is sometimes severe†§
Commonjoint swelling
RareOsteonecrosis of the jaw‡§, atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction) 
Very rareOsteonecrosis of the external auditory canal (bisphosphonate class adverse reaction).
General disorders and administration site conditions:Commonasthenia, peripheral oedema
Uncommontransient symptoms as in an acute-phase response (myalgia, malaise and rarely, fever), typically in association with initiation of treatment
§ See section 4.4

Frequency in Clinical Trials was similar in the drug and placebo group.

*See sections 4.2 and 4.4

This adverse reaction was identified through post-marketing surveillance. The frequency of rare was estimated based on relevant clinical trials.

Identified in postmarketing experience.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Symptoms

Hypocalcaemia, hypophosphataemia and upper gastro-intestinal adverse events, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdosage.

Management

No specific information is available on the treatment of overdosage with alendronate. Milk or antacids should be given to bind alendronate. Owing to the risk of oesophageal irritation, vomiting should not be induced and the patient should remain fully upright.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacodynamic properties: Drugs affecting bone structure and mineralisation, Bisphosphonates, ATC Code: M05BA04

Mechanism of action

The active ingredient of Alendronic Acid, alendronate provided as alendronate sodium trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption with no direct effect on bone formation. Preclinical studies have shown preferential localisation of alendronate to sites of active resorption. Activity of osteoclasts is inhibited, but recruitment or attachment of osteoclasts is not affected. The bone formed during treatment with alendronate is of normal quality.

Clinical efficacy and safety

Treatment of post-menopausal osteoporosis

Osteoporosis is defined as BMD of the spine or hip 2.5 SD below the mean value of a normal young population or as a previous fragility fracture, irrespective of BMD.

The therapeutic equivalence of alendronate 70mg tablets (n=519) and alendronate 10 mg daily (n=370) was demonstrated in a one-year multicentre study of post-menopausal women with osteoporosis. The mean increases from baseline in lumbar spine BMD at one year were 5.1% (95% CI: 4.8, 5.4%) in the alendronate 70mg tablets group and 5.4% (95% CI: 5.0, 5.8%) in the 10 mg daily group. The mean BMD increases were 2.3% and 2.9% at the femoral neck and 2.9% and 3.1% at the total hip in the alendronate 70mg tablets and 10 mg daily groups, respectively. The two treatment groups were also similar with regard to BMD increases at other skeletal sites.

The effects of alendronate on bone mass and fracture incidence in post-menopausal women were examined in two initial efficacy studies of identical design (n=994) as well as in the Fracture Intervention Trial (FIT: n=6,459).

In the initial efficacy studies, the mean bone mineral density (BMD) increases with alendronate 10 mg/day relative to placebo at three years were 8.8%, 5.9% and 7.8% at the spine, femoral neck and trochanter, respectively. Total body BMD also increased significantly. There was a 48% reduction (alendronate 3.2% Vs placebo 6.2%) in the proportion of patients treated with alendronate experiencing one or more vertebral fractures relative to those treated with placebo. In the two-year extension of these studies BMD at the spine and trochanter continued to increase and BMD at the femoral neck and total body were maintained.

FIT consisted of two placebo-controlled studies using alendronate daily (5 mg daily for two years and 10 mg daily for either one or two additional years):

  • FIT 1: A three-year study of 2,027 patients who had at least one baseline vertebral (compression) fracture. In this study alendronate daily reduced the incidence of ≥ 1 new vertebral fracture by 47% (alendronate 7.9% vs. placebo 15.0%). In addition, a statistically significant reduction was found in the incidence of hip fractures (1.1% vs. 2.2%, a reduction of 51%).
  • FIT 2: A four-year study of 4,432 patients with low bone mass but without a baseline vertebral fracture. In this study, a significant difference was observed in the analysis of the subgroup of osteoporotic women (37% of the global population who correspond with the above definition of osteoporosis) in the incidence of hip fractures (alendronate 1.0% vs. placebo 2.2%, a reduction of 56%) and in the incidence of ≥ 1 vertebral fracture (2.9% vs. 5.8%, a reduction of 50%).

Laboratory test findings

In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 and 10%, respectively, of patients taking alendronate 10 mg/day versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8.0 mg/dl (2.0 mmol/l) and serum phosphate to ≤2.0 mg/dl (0.65 mmol/l) were similar in both treatment groups.

Paediatric population

Alendronate sodium has been studied in a small number of patients with osteogenesis imperfecta under the age of 18 years. Results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.

5.2 Pharmacokinetic properties

Absorption

Relative to an intravenous reference dose, the oral mean bioavailability of alendronate in women was 0.64% for doses ranging from 5 to 70mg when administered after an overnight fast and two hours before a standardised breakfast. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast. In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.

Bioavailability was negligible whether alendronate was administered with, or up to two hours after, a standardised breakfast. Concomitant administration of alendronate with coffee or orange juice reduced bioavailability by approximately 60%.

In healthy subjects, oral prednisone (20 mg three times daily for five days) did not produce a clinically meaningful change in oral bioavailability of alendronate (a mean increase ranging from 20% to 44%).

Distribution

Studies in rats show that alendronate transiently distributes to soft tissues following 1 mg/kg intravenous administration but is then rapidly redistributed to bone or excreted in the urine. The mean steady-state volume of distribution, exclusive of bone, is at least 28 litres in humans. Concentrations of drug in plasma following therapeutic oral doses are too low for analytical detection (<5 ng/ml). Protein binding in human plasma is approximately 78%.

Biotransformation

There is no evidence that alendronate is metabolised in animals or humans.

Elimination

Following a single intravenous dose of [14C]alendronate, approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no radioactivity was recovered in the faeces. Following a single 10 mg intravenous dose, the renal clearance of alendronate was 71 ml/min, and systemic clearance did not exceed 200 ml/min. Plasma concentrations fell by more than 95% within six hours following intravenous administration. The terminal half-life in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton. Alendronate is not excreted through the acidic or basic transport systems of the kidney in rats, and thus it is not anticipated to interfere with the excretion of other medicinal products by those systems in humans.

Renal impairment

Preclinical studies show that the drug that is not deposited in bone is rapidly excreted in the urine. No evidence of saturation of bone uptake was found after chronic dosing with cumulative intravenous doses up to 35 mg/kg in animals. Although no clinical information is available, it is likely that, as in animals, elimination of Alendronate via the kidney will be reduced in patients with impaired renal function. Therefore, somewhat greater accumulation of alendronate in bone might be expected in patients with impaired renal function (see section 4.2).

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.

Studies in rats have shown that treatment with alendronate during pregnancy was associated with dystocia in dams during parturition that was related to hypocalcaemia. Foetuses from rats given high doses showed an increased incidence of incomplete foetal ossification. The relevance to humans in unknown.

  1. 6. PHARMACEUTICAL PARTICULARS

Each tablet contains:
Aldronate Sodium USP equivalent to
Alendronic Acid                                        70mg
Excipients                                                    q.s.

6.1 List of excipients

Cellulose, microcrystalline

Lactose monohydrate

Croscarmellose sodium

Magnesium stearate

Povidone

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

PVC/PVDC/Al blisters.

Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

No special requirements for disposal.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Alendronic Acid Tablets USP 70 mg

Package leaflet: Information for the patient

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor or
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section
WHAT IS IN THIS LEAFLET:
  1. What Aledronic Acid is and what it is used for
  2. What you need to know before you take Aledronic Acid
  3. How to take Aledronic Acid
  4. Possible side effects
  5. How to store Aledronic Acid
  6. Contents of the pack and other information

 

  1. WHAT ALEDRONIC ACID IS AND WHAT IT IS USED FOR

Aledronic Acid contains the active substance Aledronic Acid (as sodium alendronate trihydrate).

Your medicine is in the form of a tablet. Aledronic Acid belongs to a group of non- hormonal medicines called bisphosphonates. Bisphosphonates can be used to help bone disease such as osteoporosis. Aledronic Acid can treat and prevent osteoporosis in post- menopausal women, by stopping bones becoming thinner and weaker.

How can osteoporosis be treated?

As well as your treatment with Aledronic Acid, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Stopping smoking        Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise              Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Eating a balanced diet your doctor can advise you about your diet or whether you should take any dietary supplements (especially calcium and Vitamin D).

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALEDRONIC ACID
    DO NOT TAKE ALEDRONIC ACID:
  • if you are allergic to Aledronic Acid or any of the other ingredients of this medicine (listed in section 6)
  • if you have problems with your gullet (oesophagus – the tube that connects your mouth with your stomach) causing difficulty swallowing or food to become stuck
  • if you know you have very low blood levels of calcium (hypocalcaemia)
  • If you are unable to stand or sit upright for at least 30 \

Warnings and precautions:

Talk to your doctor or pharmacist before taking Aledronic Acid:

  • if you suffer from kidney problems
  • if you have any swallowing or digestive or gut problems or if in the last year you have had a stomach ulcer, bleed or surgery in the stomach, gullet or throat
  • if you have pain on swallowing
  • if you have been told you have low blood levels of calcium or you suffer from vitamin D deficiency or hypoparathyroidism (which can affect calcium levels). These need to be treated before you start taking Aledronic Acid
  • if your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells that line the lower oesophagus)

Irritation, inflammation or ulceration of the gullet often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if the tablets are not taken with a full glass of water and/or if you lie down less than 30 minutes after taking the tablets. These side effects may worsen if you continue to take the tablets after developing these symptoms. See the ‘How to take’ instructions later on in this leaflet to see how you should take the tablets. If you have any questions, ask your doctor or pharmacist.

Dental and jaw problems

Aledronic Acid can cause damage, including the death or loss of bone in the jaw. This risk is increased:

  • if you have poor dental health, gum disease, poorly fitted dentures, a planned dental extraction or you do not receive routine dental care
  • if you have cancer
  • if you are undergoing chemotherapy or radiotherapy
  • if you are taking corticosteroids (such as prednisone or dexamethasone)
  • if you are taking angiogenesis inhibitors – medicines used in the treatment of cancer to prevent the growth of new blood vessels, such as bevacizumab or thalidomide
  • if you are or have been a smoker

Therefore you may be advised to have a dental check-up before starting treatment with Aledronic Acid.

It is important to maintain good oral hygiene when being treated with Aledronic Acid. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

Children and adolescents:

Aledronic Acid should not be given to children and adolescents less than 18 years of age.

Other medicines and ALEDRONIC ACID:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, or any of the following:\

  • calcium supplements
  • antacids for indigestion
  • corticosteroid medicines, such as prednisone or dexamethasone, used to reduce inflammation; as it is important that you have a good dietary intake of calcium and vitamin D (a risk factor for dental problems – see ‘Dental and jaw problems’)
  • certain medicines for rheumatism or long-term pain called NSAIDs (e.g. aspirin or ibuprofen) might cause digestive problems. Therefore, caution should be used when these medicines are taken at the same time as Aledronic Acid.

Wait at least 30 minutes after taking Aledronic Acid before taking any other medicines.

ALEDRONIC ACID with food and drink:

If taken at the same time it is likely that food and drink (including mineral water) will interfere with the absorption of Aledronic Acid. Therefore you should take Aledronic Acid with plain water at least 30 minutes before any food or drink.

Pregnancy and breast-feeding:

Aledronic Acid is only intended for use in post-menopausal women. Do not take Aledronic Acid if you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There have been side effects (including blurred vision, dizziness and severe bone, muscle or joint pain) reported with Aledronic Acid that may affect your ability to drive or operate machinery. Do not drive or operate machinery until you are sure you are not affected.

Aledronic Acid contains lactose. If you have been told by your doctor that you have

an intolerance to some sugars, contact your doctor before taking this medicine.

Aledronic Acid contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’

  1. HOW TO TAKE ALEDRONIC ACID

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet once weekly.

Use in patients with kidney problems:

Aledronic Acid is not recommended for patients with severe kidney problems.

Method of administration:

  • Take on an empty stomach, as soon as you get out of bed in the morning, before you eat or drink
  • Swallow the tablet whole while staying in an upright position (sitting, standing or walking). Take with a full glass (not less than 200 ml) of plain water (not mineral water).
    • Do not take with mineral water (still or sparkling).
    • Do not take with coffee or
    • Do not take with juice or
    • Do not crush or chew or let the tablet dissolve in your
  • Do not take at bedtime. You should not lie down after taking Aledronic Acid until you have had something to
  • However, you must leave at least 30 minutes after swallowing the tablet before you eat, drink or take any other

Stop taking this medicine and tell your doctor if you notice:

  • soreness, pain and difficulty swallowing
  • pain in the centre of the chest
  • heartburn, either new or worse than usual
  • ulcers in your mouth and

If you take more ALEDRONIC ACID than you should:

Drink a full glass of milk and contact your doctor or nearest hospital casualty department immediately. Take any remaining tablets and the container with you. Do not make yourself vomit, and do not lie down. In case of an overdose, you may experience an upset stomach, heartburn, stomach pain, nausea, vomiting, vomiting blood, blood in the bowel motions.

If you forget to take ALEDRONIC ACID:

Take the tablet in the morning after you remember. Do not take two tablets on the same day and return to taking one tablet once a week, on the day instructed by your doctor.

If you stop taking ALEDRONIC ACID:

Always talk to your doctor or pharmacist before you stop taking Aledronic Acid.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking this medicine and tell your doctor immediately if you experience any of the following symptoms:

Common (may affect up to 1 in 10 people):

  • pain in the mouth, throat, chest or stomach which may be associated with eating. You may feel bloated, sick or be sick, have a loss of appetite or have a loss of weight. These may be signs of inflammation or ulceration in the digestive tract. If you are sick, you may also notice particles that looks like coffee grounds or you may pass black, tar-like stools
  • new or worsening heartburn or indigestion, pain in the centre of chest or pain upon swallowing or difficulty swallowing. See your doctor as soon as possible if you have any of these effects

Uncommon (may affect up to 1 in 100 people):

  • soreness or pain in one or both eyes. You may have redness, blurred vision, watery eyes, a sensitivity to light or floaters (shadows passing across your sight)

Rare (may affect up to 1 in 1,000 people):

allergic reactions such as hives, swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing (angioedema)

  • a skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome) or severe skin reactions which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis)
  • pain in the mouth, and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction
  • unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone

Very rare (may affect up to 1 in 10,000 people):

  • talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the

Contact your doctor or dentist if you experience such symptoms.

Other possible side effects:

Very common (may affect more than 1 in 10 people):

  • bone, muscle and/or joint pain which is sometimes

Common (may affect up to 1 in 10 people):

  • joint swelling, swelling of the hands and legs
  • abdominal pain, uncomfortable or full feeling in the stomach or belching after eating; constipation, diarrhoea, flatulence
  • hair loss, itchy skin
  • headache, dizziness, loss of balance or spinning sensation (vertigo), unusual weakness

Uncommon (may affect up to 1 in 100 people):

  • nausea, vomiting
  • rash, redness of the skin
  • for a short time flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever. This is usually seen at the start of treatment
  • changes in your

Rare (may affect up to 1 in 1,000 people):

  • symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
  • narrowing of the gullet (oesophageal stricture)
  • rash made worse by sunlight

Tell your doctor or pharmacist promptly about these or any other unusual symptoms.

It will help if you make a note of what you experienced, when it started and how long it lasted.

Reporting of side effect

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

  1. HOW TO STORE ALEDRONIC ACID

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label, carton and blister after “EXP”. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.\

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What ALEDRONIC ACID contains:

Each tablet contains:
Aldronate Sodium USP equivalent to
Alendronic Acid                                       70mg
Excipients                                                      q.s.

What Sodium Aledronate looks like and contents of the pack:|
PVC/PVDC/Al blisters.|
Pack sizes: Blisters: 7, 14, 28, 30, 50, 90, 100 and 500mg modified-release tablets.\
Not all pack sizes may be marketed.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com