1. NAME OF THE MEDICINAL PRODUCT

Fexofenadine Hydrochloride tablets 120mg Taj Pharma
Fexofenadine Hydrochloride tablets 180mg Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION 

    a) Each film-coated tablet contains:
    fexofenadine hydrochloride, equivalent to
    112mg of fexofenadine……………..120mg
    Excipients……………………………….q.s.b) Each film-coated tablet contains:
    fexofenadine hydrochloride, equivalent to
    168mg of fexofenadine……………..180mg
    Excipients……………………………….q.s.

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Film-coated tablet.

  1. CLINICAL PARTICULARS

4.1 Therapeutic indications

Fexofenadine hydrochloride 120mg / 180mg tablet is indicated in adults and children 12 years and older for the relief of symptoms associated with chronic idiopathic urticaria.

4.2 Posology and method of administration

Posology

Adults

The recommended dose of fexofenadine hydrochloride for adults is 120mg / 180mg once daily taken before a meal.

Fexofenadine is a pharmacologically active metabolite of terfenadine.

Paediatric population

Adolescents aged 12 years and over

The recommended dose of fexofenadine hydrochloride for adolescents aged 12 years and over is 120mg / 180mg once daily taken before a meal.

Children under 12 years of age

The efficacy and safety of fexofenadine hydrochloride 120mg / 180mg has not been studied in children under 12.

Special populations

Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

Method of administration

Fexofenadine hydrochloride tablet is for oral use.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients.

Fexofenadine hydrochloride should be administered with care in these special groups.

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations (see section 4.8).

Excipient

This medicine 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

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other medicinal products through hepatic mechanisms. Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.

Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.

No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no adequate data from the use of fexofenadine hydrochloride in pregnant women.

Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3)Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.

Breast-feeding

There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breast-feeding their babies.

Fertility

No human data on the effect of fexofenadine hydrochloride on fertility are available. In mice, there was no effect on fertility with fexofenadine hydrochloride treatment (see section 5.3).

4.7 Effects on ability to drive and use machines

On the basis of the pharmacodynamic profile and reported adverse reactions it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, fexofenadine has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.

4.8 Undesirable effects

The following frequency rating has been used, when applicable:

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;

Not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo:

Nervous system disorders

Common: headache, drowsiness, dizziness

Gastrointestinal disorders

Common: nausea

General disorders and administration site conditions

Uncommon: fatigue

In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not be estimated from available data):

Immune system disorders

Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis

Psychiatric disorders

Insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria)

Cardiac disorders

Tachycardia, palpitations

Gastrointestinal disorders

Diarrhoea

Skin and subcutaneous tissue disorders

Rash, urticaria, pruritus

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.

4.9 Overdose

Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg, and doses up to 690 mg twice daily for 1 month, or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established.

Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antihistamines for systemic use

Mechanism of action

Fexofenadine hydrochloride is a non-sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine.

Clinical efficacy and safety

Human histamine wheal and flare studies following single and twice daily doses of fexofenadine hydrochloride demonstrate that the medicinal products exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours. There is no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10 mg to 130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hour period. Maximum inhibition in skin wheal and flare areas was greater than 80%.

No significant differences in QTc, intervals were observed in seasonal allergic rhinitis patients given fexofenadine hydrochloride up to 240 mg twice daily for 2 weeks when compared to placebo. Also, no significant change in QTc intervals was observed in healthy subjects given fexofenadine hydrochloride up to 60 mg twice daily for 6 months. 400 mg twice daily for 6.5 days and 240 mg once daily for 1 year, when compared to placebo.

Fexofenadine at concentrations 32 times greater than the therapeutic concentration in man had no effect on the delayed rectifier K+ channel cloned from human heart.

Fexofenadine hydrochloride (5-10 mg/kg per orally) inhibited antigen induced bronchospasm in sensitised guinea pigs and inhibited histamine release at supra- therapeutic concentrations (10- 100 µM) from peritoneal mast cells.

5.2 Pharmacokinetic properties

Absorption

Fexofenadine hydrochloride is rapidly absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 494 ng/ml following the administration of a 120mg / 180mg dose once daily.

Distribution

Fexofenadine is 60-70% plasma protein bound.

Biotransformation and elimination

Fexofenadine undergoes negligible metabolism (hepatic or non-hepatic), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours after multiple dosing. The single and multiple dose pharmacokinetics of fexofenadine are linear for oral doses up to 120 mg BID. A dose of 240 mg BID produced slightly greater than proportional increase (8.8%) in steady state area under the curve, indicating that fexofenadine pharmacokinetics are practically linear at these doses between 40mg and 240 mg taken daily. The major route of elimination is believed to be via biliary excretion while up to 10% of ingested dose is excreted unchanged through the urine.

5.3 Preclinical safety data

Dogs tolerated 450 mg/kg administered twice daily for 6 months and showed no toxicity other than occasional emesis. Also, in single dose dog and rodent studies, no treatment-related gross findings were observed following necropsy.

Radiolabelled fexofenadine hydrochloride in tissue distribution studies of the rat indicated that fexofenadine did not cross the blood brain barrier.

Fexofenadine hydrochloride was found to be non-mutagenic in various in vitro and in vivo mutagenicity tests.

The carcinogenic potential of fexofenadine hydrochloride was assessed using terfenadine studies with supporting pharmacokinetic studies showing fexofenadine hydrochloride exposure (via plasma AUC values). No evidence of carcinogenicity was observed in rats and mice given terfenadine (up to 150 mg/kg/day).

In a reproductive toxicity study in mice, fexofenadine hydrochloride did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core: Microcrystalline cellulose, Maize starch, Magnesium stearate, Croscarmellose sodium, Povidone.

Film-coating: Hypromellose, Macrogol, Macrogol, Titanium dioxide, Iron oxide yellow, Iron oxide Red

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store the tablets in the original package. This medicinal product does not require any special temperature storage conditions.

6.5 Nature and contents of container

PVC/PVDC/Alu blister packs of 7, 10, 15, 20, 30, 50, 100 or 500 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

FEXOFINADINE HYDROCHLORIDE TABLETS USP
120MG / 180MG
TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Fexofinadine

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 again.
  • If you have any further questions, ask your doctor or pharmacist.
  • 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 yours.
  • 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 4).

WHAT IS IN THIS LEAFLET

  1. What Fexofinadine Tablets is and what it is used for
  2. What you need to know before you take Fexofinadine Tablets
  3. How to take Fexofinadine Tablets
  4. Possible side effects
  5. How to store Fexofinadine Tablets
  6. Contents of the pack and other information1. WHAT FEXOFINADINE TABLETS IS AND WHAT IT IS USED FOR

Fexofinadine Tablets contain the active substance Fexofinadine. It belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing the amount of acid that your stomach produces. Fexofinadine Tablets are used to treat the following conditions:

In adults:

  • ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
  • Ulcers in the upper part of the intestine (duodenal ulcer) or stomach (gastric ulcer).
  • Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  • Ulcers caused by medicines called NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Fexofinadine Tablets can also be used to stop ulcers from forming if you are taking NSAIDs.
  • Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

  • ‘Gastro-oesophageal reflux disease’ (GORD). This is where acid from the stomach escapes into the gullet (the tube which connects your throat to your stomach) causing pain, inflammation and heartburn.
    In children, the symptoms of the condition can include the return of stomach contents into the mouth (regurgitation), being sick (vomiting) and poor weight gain.

Children and adolescents over 4 years of age

  • Ulcers which are infected with bacteria called ‘Helicobacter pylori’. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFINADINE TABLETS

Do not take Fexofinadine Tablets:

  • If you are allergic (hypersensitive) to Fexofinadine Tablets or any of the other ingredients of Fexofinadine Tablets (listed in section 6)
  • If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esFexofinadine Tablets)
  • If you are taking a medicine containing nelfinavir (used for HIV infection).

If you are not sure, talk to your doctor or pharmacist before taking Fexofinadine Tablets.

Warnings and precautions

Fexofinadine Tablets may hide the symptoms of other diseases. Therefore, if any of the following happen to you before you start taking Fexofinadine Tablets or while you are taking them, talk to your doctor straightaway:

  • You lose a lot of weight for no reason and have problems swallowing.
  • You get stomach pain or indigestion.
  • You begin to vomit food or vomit blood.
  • You pass black stools (blood-stained faeces).
  • You experience severe or persistent diarrhoea, as Fexofinadine Tablets has been associated with a small increase in infectious diarrhoea.
  • You have severe liver problems.
  • You have ever had a skin reaction after treatment with a medicine similar to Fexofinadine Tablets that reduces stomach acid.

Taking a proton pump inhibitor like Fexofinadine Tablets, especially over a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you take Fexofinadine Tablets on a long-term basis (longer than 1 year) your doctor will probably keep you under regular surveillance. You should report any new and exceptional symptoms and circumstances whenever you see your doctor.

If you get a rash on your skin, especially in areas exposed to the sun tell your doctor as soon as you can as you may need to stop your treatment with Fexofinadine Tablets. Remember to also mention any other ill-effects like pain in your joints.

Tell your doctor before taking this medicine if you are due to have a specific blood test (Chromogranin A).

Other medicines and Fexofinadine Tablets

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is because Fexofinadine Tablets can affect the way some medicines work and some medicines can have an effect on Fexofinadine Tablets.

Do not take Fexofinadine Tablets if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

  • Ketoconazole, itroconazole, posaconazole or voriconazole (used to treat infections caused by a fungus)
  • Digoxin (used to treat heart problems)
  • Diazepam (used to treat anxiety, relax muscles or in epilepsy)
  • Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop taking Fexofinadine Tablets
  • Medicines used to thin the blood, such as warfarin or other vitamin K blockers. Your doctor may need to monitor you when you start or stop taking Fexofinadine Tablets
  • Rifampicin (used to treat tuberculosis)
  • Atazanavir (used to treat HIV infection)
  • Tacrolimus (in cases of organ transplantation)
  • St John’s wort (hypericum perforatum) (used to treat mild depression)
  • Cilostazol (used to treat intermittent claudication)
  • Saquinavir (used to treat HIV infection)
  • Clopidogrel (used to prevent blood clots (thrombi))
  • Erlotinib (used to treat cancer)
  • Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor may temporarily stop your Fexofinadine Tablets treatment.

If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as Fexofinadine Tablets to treat ulcers caused by Helicobacter pylori infection, it is very important that you tell your doctor about any other medicines you are taking.

Fexofinadine Tablets with food and drink

You can take your Tablets with food or on an empty stomach.

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Fexofinadine Tablets is excreted in breast milk but is not likely to influence the child when therapeutic doses are used. Your doctor will decide whether you can take Fexofinadine Tablets if you are breast-feeding.

Driving and using machines

Fexofinadine Tablets is not likely to affect your ability to drive or use any tools or machines. Side effects such as dizziness and visual disturbances may occur (see section 4). If affected, you should not drive or operate machinery.

  1. HOW TO TAKE FEXOFINADINE TABLETS

Always take Fexofinadine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Tablets to take, and how long to take them for. This will depend on your condition and how old you are. The usual doses are given below.

Adults:

To treat symptoms of GORD such as heartburn and acid regurgitation:

  • If your doctor has found that your food pipe (gullet) has been slightly damaged, the recommended dose is 20 mg once a day for 4-8 weeks. Your doctor may tell you to take a dose of 40 mg for a further 8 weeks if your gullet has not yet healed.
  • The recommended dose once the gullet has healed is 10 mg once a day.
  • If your gullet has not been damaged, the recommended dose is 10 mg once a day.

To treat ulcers in the upper part of the intestine (duodenal ulcer):

  • The recommended dose is 20 mg once a day for 2 weeks. Your doctor may tell you to take the same dose for a further 2 weeks if your ulcer has not yet healed.
  • If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 4 weeks.

To treat ulcers in the stomach (gastric ulcer):

  • The recommended dose is 20 mg once a day for 4 weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your ulcer has not yet healed.
  • If the ulcer does not fully heal, the dose can be increased to 40 mg once a day for 8 weeks.

To prevent the duodenal and stomach ulcers from coming back:

  • The recommended dose is 10 mg or 20 mg once a day. Your doctor may increase the dose to 40 mg once a day.

To treat duodenal and stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory Drugs):

  • The recommended dose is 20 mg once a day for 4–8 weeks.

To prevent duodenal and stomach ulcers if you are taking NSAIDs:

  • The recommended dose is 20 mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

  • The recommended dose is 20 mg Fexofinadine Tablets twice a day for one week.
  • Your doctor will also tell you to take two antibiotics among amoxicillin, clarithromycin and metronidazole.

To treat too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison syndrome):

  • The recommended dose is 60 mg daily.
  • Your doctor will adjust the dose depending on your needs and will also decide how long you need to take the medicine for.

Use in Children:

To treat symptoms of GORD such as heartburn and acid regurgitation:

  • Children over 1 year of age and with a body weight of more than 10 kg may take Fexofinadine Tablets. The dose for children is based on the child’s weight and the doctor will decide the correct dose.

To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:

  • Children aged over 4 years may take Fexofinadine Tablets. The dose for children is based on the child’s weight and the doctor will decide the correct dose.
  • Your doctor will also prescribe two antibiotics called amoxicillin and clarithromycin for your child.

Taking this medicine

  • It is recommended that you take your Tablets in the morning.
  • You can take your Tablets with food or on an empty stomach.
  • Swallow your Tablets whole with half a glass of water. Do not chew or crush the Tablets. This is because the Tablets contain coated pellets which stop the medicine from being broken down by the acid in your stomach. It is important not to damage the pellets.

What to do if you or your child have trouble swallowing the Tablets

If you or your child have trouble swallowing the Tablets:

  • Open the Tablets and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
  • Always stir the mixture just before drinking it (the mixture will not be clear). Then drink the mixture straight away or within 30 minutes.
  • To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it. The solid pieces contain the medicine – do not chew or crush them.

If you take more Fexofinadine Tablets than you should

If you take more Fexofinadine Tablets than prescribed by your doctor, talk to your doctor or pharmacist straight away.

If you forget to take Fexofinadine Tablets

If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

  1. POSSIBLE SIDE EFFECT

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

If you notice any of the following rare but serious side effects stop taking Fexofinadine Tablets and contact a doctor immediately

  • Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or difficulties in swallowing (severe allergic reaction).
  • Reddening of the skin with blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals – this could be ‘Stevens-Johnson Syndrome’ or ‘toxic epidermal necrolysis’.
  • Yellow skin, dark urine and tiredness which can be symptoms of liver problems.

Other side effects include:

Common side effects (may affect up to 1 in 10 people)

  • Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind (flatulence).
  • Feeling sick (nausea) or being sick (vomiting).
  • Benign polyps in the stomach.

Uncommon side effects (may affect up to 1 in 100 people)

  • Swelling of the feet and ankles.
  • Disturbed sleep (insomnia).
  • Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
  • Spinning feeling (vertigo).
  • Changes in blood tests that check how the liver is working.
  • Skin rash, lumpy rash (hives) and itchy skin.
  • Generally feeling unwell and lacking energy.

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

  • Blood problems such as a reduced number of white cells or platelets. This can cause weakness, bruising or make infections more likely.
  • Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing.
  • Low levels of sodium in the blood. This may cause weakness, being sick (vomiting) and cramps.
  • Feeling agitated, confused or depressed.
  • Taste changes.
  • Eyesight problems such as blurred vision.
  • Suddenly feeling wheezy or short of breath (bronchospasm).
  • Dry mouth.
  • An inflammation of the inside of the mouth.
  • An infection called “thrush” which can affect the gut and is caused by a fungus.
  • Liver problems, including jaundice which can cause yellow skin, dark urine, and tiredness.
  • Hair loss (alopecia).
  • Skin rash on exposure to sunshine.
  • Joint pains (arthralgia) or muscle pains (myalgia).
  • Severe kidney problems (interstitial nephritis).
  • Increased sweating.

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

  • Changes in blood count including agranulocytosis (lack of white blood cells).
  • Seeing, feeling or hearing things that are not there (hallucinations).
  • Severe liver problems leading to liver failure and inflammation of the brain.
  • Sudden onset of a severe rash or blistering or peeling skin. This may be associated with a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • Muscle weakness.
  • Enlarged breasts in men.

Not known (frequency cannot be estimated from the available data)

  • Inflammation in the gut (leading to diarrhoea).
  • If you are on Fexofinadine Tablets for more than three months it is possible that the levels of magnesium in your blood may fall. Low levels of magnesium can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you get any of these symptoms, please tell your doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
  • Rash, possibly with pain in the joints.

Fexofinadine Tablets may in very rare cases affect the white blood cells leading to immune deficiency.

If you have an infection with symptoms such as fever with a severely reduced general condition or fever with symptoms of a local infection such as pain in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a blood test. It is important for you to give information about your medicine at this time.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

  1. HOW TO STORE FEXOFINADINE TABLETS

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 pack after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store this blister in the original package.

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

  1. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Fexofinadine Tablets contain

a) Each film-coated tablet contains:
fexofenadine hydrochloride, equivalent to
112mg of fexofenadine……………..120mg
Excipients……………………………….q.s.

b) Each film-coated tablet contains:
fexofenadine hydrochloride, equivalent to
168mg of fexofenadine……………..180mg
Excipients……………………………….q.s.

The other ingredients are mannitol, crospovidone, hypromellose, poloxamer, meglumine, povidone, methacrylic acid ethyl acrylate copolymer, triethyl citrate and magnesium stearate.

What Fexofinadine Tablets look like and contents of the pack
The granules are supplied in a hard gelatin capsule shell with a purple cap and light grey body.
The capsule shell is composed of gelatin, titanium dioxide E171, erythrosine E127, patent blue V E131, black iron oxide E172. The printing ink is composed of shellac glaze, black iron oxide E172, propylene glycol and ammonium hydroxide.

Fexofinadine Tablets are supplied in boxes containing 7, 14 or 28 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