Cabergoline Tablets USP 1mg Taj Pharma

Cabergoline Tablets USP 0.5mg, 1mg, 2 mg Taj Pharma

1.Name of the medicinal product
Cabergoline Tablets 0.5mg, 1mg, 2 mg Taj Pharma

2.Qualitative and quantitative composition

a) Cabergoline Tablets USP 0.5mg
Each Tablet contains:
Cabergoline                            0.5mg

Excipients                                q.s.

b) Cabergoline Tablets USP 1mg
Each Tablet contains:
Cabergoline                            1mg
Excipients                                q.s.

c) Cabergoline Tablets USP 2mg
Each Tablet contains:
Cabergoline                            2mg

Excipients                                q.s.

Excipient(s) with known effect:

Each tablet contains 150.8 mg of lactose.

For the full list of excipients, see section 6.1.

3.Pharmaceutical form

Tablet

White, oval.

4.Clinical particulars

4.1 Therapeutic indications

Treatment of Parkinson’s disease

If treatment with a dopamine agonist is being considered, cabergoline is indicated as second line therapy in patients who are intolerant or fail treatment with a non-ergot compound, as monotherapy, or as adjunctive treatment to levodopa plus dopa-decarboxylase inhibitor, in the management of the signs and symptoms of Parkinson’s disease.

Treatment should be initiated under specialist supervision. The benefit of continued treatment should be regularly reassessed taking into account the risk of fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8).

4.2 Posology and method of administration

Posology

Since the tolerability of dopaminergic agents is improved when administered with food, it is recommended that cabergoline be taken with meals.

Cabergoline is intended for chronic, long term treatment.

Adults and elderly patients

As expected for dopamine agonists, dose response for both efficacy and side effects appears to be linked to individual sensitivity. Optimization of dose should be obtained through slow initial dose titration, from starting doses of 1 mg daily. The dosage of concurrent levodopa may be gradually decreased, while the dosage of cabergoline is increased, until the optimum balance is determined. In view of the long half-life of the compound, increments of the daily dose of 0.5-1 mg should be done at weekly (initial weeks) or bi-weekly intervals, up to optimal doses.

The recommended therapeutic dosage is 2 mg to 3 mg/day for patients with signs and symptoms of Parkinson’s disease. Cabergoline should be given as a single daily dose.

Paediatric population

The safety and efficacy of cabergoline has not been investigated in children as Parkinson’s disease does not affect this population.

Method of administration

The tablets are for oral administration.

4.3 Contraindications

  • Hypersensitivity to cabergoline or to any of the excipients listed in section 6.1, or any ergot alkaloid.
  • History of pulmonary, pericardial and retroperitoneal fibrotic disorders.

For long-term treatment:

  • Evidence of cardiac valvulopathy as determined by pre-treatment echocardiography. (see section 4.4).

4.4 Special warnings and precautions for use

General

As with other ergot derivatives, cabergoline should be given with caution to patients with severe cardiovascular disease, Raynaud’s syndrome, peptic ulcer or gastrointestinal bleeding, or with a history of serious, particularly psychotic, mental disorders.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

The effects of alcohol on overall tolerability of Cabergoline are currently unknown.

Hepatic Insufficiency

Lower doses of cabergoline should be considered in patients with severe hepatic insufficiency. Compared to normal volunteers and those with lesser degrees of hepatic insufficiency, an increase in AUC has been seen in patients with severe hepatic insufficiency (Child-Pugh Class C) who received a single 1 mg dose.

Postural Hypotension

Postural hypotension can occur following administration of cabergoline, particularly during the first days of administration of cabergoline. Care should be exercised when administering cabergoline concomitantly with other drugs known to lower blood pressure.

Fibrosis and Cardiac Valvulopathy and Possibly Related Clinical Phenomena

Fibrotic and serosal inflammatory disorders such as pleuritis, pleural effusion, pleural fibrosis, pulmonary fibrosis, pericarditis, pericardial effusion, cardiac valvulopathy involving one or more valves (aortic, mitral and tricuspid) or retroperitoneal fibrosis have occurred after prolonged usage of ergot derivatives with agonist activity at the serotonin 5HT2B receptor, such as cabergoline. In some cases, symptoms or manifestations of cardiac valvulopathy improved after discontinuation of cabergoline.

Erythrocyte sedimentation rate (ESR) has been found to be abnormally increased in association with pleural effusion/fibrosis. Chest x-ray examination is recommended in cases of unexplained ESR increases to abnormal values.

Serum creatinine measurements can also be used to help in the diagnosis of fibrotic disorder. Following diagnosis of pleural effusion/pulmonary fibrosis or valvulopathy, the discontinuance of cabergoline has been reported to result in improvement of signs and symptoms (see section 4.3).

Valvulopathy has been associated with cumulative doses, therefore patients should be treated with the lowest effective dose. At each visit, the risk benefit profile of cabergoline treatment for the patient should be reassessed to determine the suitability of continued treatment with cabergoline.

Before initiating long-term treatment

All patients must undergo a cardiovascular evaluation, including echocardiogram, to assess the potential presence of asymptomatic valvular disease. It is also appropriate to perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest x-ray and renal function prior to initiation of therapy. In patients with valvular regurgitation, it is not known whether cabergoline treatment might worsen the underlying disease. If fibrotic valvular disease is detected, the patient should not be treated with cabergoline (see section 4.3).

During long-term treatment

Fibrotic disorders can have an insidious onset and patients should be regularly monitored for possible manifestations of progressive fibrosis. Therefore during treatment, attention should be paid to the signs and symptoms of:

  • Pleuro-pulmonary disease, such as dyspnoea, shortness of breath, persistent cough, or chest pain.
  • Renal insufficiency or ureteral/abdominal vascular obstruction that may occur with pain in the loin/flank, and lower limb oedema, as well as any possible abdominal masses or tenderness that may indicate retroperitoneal fibrosis.
  • Cardiac failure; cases of valvular and pericardial fibrosis have often manifested as cardiac failure. Therefore, valvular fibrosis (and constrictive pericarditis) should be excluded if such symptoms occur.

Clinical diagnostic monitoring for development of fibrotic disorders, as appropriate, is essential. Following treatment initiation, the first echocardiogram must occur within 3-6 months, thereafter, the frequency of echocardiographic monitoring should be determined by appropriate individual clinical assessment with particular emphasis on the above-mentioned signs and symptoms, but must occur at least every 6 to 12 months.

Cabergoline should be discontinued if an echocardiogram reveals new or worsened valvular regurgitation, valvular restriction, valve leaflet thickening or fibrotic valvular disease (see section 4.3).

The need for other clinical monitoring (e.g. physical examination including, cardiac auscultation, X-ray, CT scan) should be determined on an individual basis.

Additional appropriate investigations such as erythrocyte sedimentation rate, and serum creatinine measurements should be performed if necessary to support a diagnosis of a fibrotic disorder.

Somnolence/Sudden Sleep Onset

Cabergoline has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson’s disease. Sudden onset of sleep during activities, in some cases without awareness or warning signs, has been reported. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with cabergoline. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. A reduction of dosage or termination of therapy may be considered (see section 4.7).

Impulse control disorders

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Cabergoline. Dose reduction/tapered discontinuation should be considered if such symptoms develop.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant use of antiparkinson non-dopamine agonists (e.g. selegiline, amantadine, biperiden, trihexyphenidyl) was allowed in clinical studies for patients receiving cabergoline. In studies where the pharmacokinetic interactions of cabergoline with L-dopa or selegiline were evaluated, no interactions were observed.

No information is available about interaction between cabergoline and other ergot alkaloids: therefore the concomitant use of these medications during long term treatment with cabergoline is not recommended.

Since cabergoline exerts its therapeutic effect by direct stimulation of dopamine receptors, it should not be concurrently administered with drugs which have dopamine antagonist activity (such as phenothiazines, butyrophenones, thioxanthenes, metoclopramide) since these might reduce the therapeutic effect of cabergoline.

As with other ergot derivatives, cabergoline should not be used in association with macrolide antibiotics (e.g. erythromycin) due to increased systemic bioavailability.

4.6 Fertility, pregnancy and lactation

There are no adequate and well-controlled studies from the use of cabergoline in pregnant women. Animal studies have not demonstrated teratogenic effects, but reduced fertility and embryo-toxicity were observed in association with pharmacodynamic activity (see section 5.3).

In a twelve year observational study on pregnancy outcomes following cabergoline therapy, information is available on 256 pregnancies. Seventeen of these 256 pregnancies (6.6%) eventuated in major congenital malformations or abortion. Information is available on 23/258 infants who had a total of 27 neonatal abnormalities, both major and minor. Musculoskeletal malformations were the most common neonatal abnormality (10), followed by cardio-pulmonary abnormalities (5). There is no information on perinatal disorders or long-term development of infants exposed to intra-uterine cabergoline. Based on recent published literature, the prevalence of major congenital malformations in the general population has been reported to be 6.9% or greater. Rates of congenital abnormality vary between different populations. It is not possible to accurately determine if there is an increased risk as no control group was included.

It is recommended that contraception is used whilst on treatment with cabergoline.

Cabergoline should only be used during pregnancy if clearly indicated and after an accurate benefit/risk evaluation.

Due to the long half-life of the drug and limited data on in utero exposure, women planning to become pregnant should discontinue cabergoline one month before intended conception. If conception occurs during therapy, treatment should be discontinued as soon as pregnancy is confirmed to limit foetal exposure to the drug.

In rats, cabergoline and/or its metabolites are excreted in milk. No information is available on excretion in breast milk in humans; however, lactation is expected to be inhibited/suppressed by cabergoline, in view of its dopamine agonist properties. Mothers should be advised not to breast-feed while being treated with cabergoline.

4.7 Effects on ability to drive and use machines

Patients should be careful when performing actions which require fast and accurate reaction during treatment initiation.

Patients being treated with cabergoline and presenting with somnolence and/or sudden sleep onset episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such episodes and somnolence have resolved (see section 4.4).

4.8 Undesirable effects

The following undesirable effects have been observed and reported during treatment with cabergoline with the following frequencies: 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 (cannot be estimated from the available data).

MedDRA

System Organ Class

Frequency Undesirable Effects
Cardiac disorders Very Common Valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion)
Common* Angina pectoris
Respiratory, thoracic and mediastinal disorders Common Dyspnoea
Uncommon Pleural effusion, pulmonary fibrosis
Very rare Fibrosis ( including pleural fibrosis)
Not Known Respiratory disorder, respiratory failure, pleuritis, chest pain
Immune system disorders Uncommon Hypersensitivity reaction
Nervous system disorders Common Headache, somnolence, dizziness/vertigo, dyskinesia
Uncommon Hyperkinesia
Not Known Sudden sleep onset, syncope, tremor
Eye disorders Not Known Visual impairment
Psychiatric disorders Common Hallucinations, sleep disturbances, increased libido, confusion
Uncommon Delusions, psychotic disorder
Not Known Aggression, hypersexuality, pathological gambling
Vascular disorders Common Cabergoline generally exerts a hypotensive effect in patients on long-term treatment; Postural hypotension
Uncommon Erythromelalgia
Not Known Digital vasospasm
Gastrointestinal disorders Very common Nausea
Common Constipation, dyspepsia, gastritis, vomiting
General disorders and administration site conditions Very common Peripheral oedema
Common Asthenia
Uncommon Oedema, fatigue
Hepatobiliary disorders Uncommon Hepatic function abnormal
Skin and subcutaneous tissue disorders Uncommon Rash
Not Known Alopecia
Musculoskeletal and connective tissue disorders Not Known Leg cramps
Investigations Common Liver function tests abnormal, decreased haemoglobin, haematocrit, and/or red blood cell (>15% vs baseline)
Not Known Blood creatinine phosphokinase increased

* When concomitant use with levodopa therapy

Impulse control disorders

Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including Cabergoline (see section 4.4).

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.

4.9 Overdose

Symptoms of overdose would likely be those of over-stimulation of dopamine receptors, e.g. nausea, vomiting, gastric complaints, postural hypotension, confusion/psychosis or hallucinations.

Supportive measures should be taken to remove unabsorbed drug and maintain blood pressure, if necessary. In addition, the administration of dopamine antagonist drugs may be advisable.

5.Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Dopamine agonists.

Cabergoline is a dopaminergic ergoline derivative endowed with potent and long-lasting dopamine D2 receptor agonist properties. In rats the compound, acting at D2 dopamine receptors on pituitary lactotrophic cells, decreases PRL secretion at oral doses of 3-25 mcg/kg, and in vitro at a concentration of 45 pg/ml. In addition, cabergoline exerts a central dopaminergic effect via D2 receptor stimulation at doses higher than those effective in lowering serum PRL levels. Improvement of motor deficit in animal models of Parkinson’s disease was present at oral daily doses of 1-2.5 mg/kg in rats and at s.c. doses of 0.5-1 mg/kg in monkeys.

In healthy volunteers the administration of cabergoline at single oral doses of 0.3-2.5 mg was associated with a significant decrease in serum PRL levels. The effect is prompt (within 3 hours of administration) and persistent (up to 7-28 days). The PRL-lowering effect is dose-related both in terms of degree of effect and duration of action.

The pharmacodynamic actions of cabergoline not linked to the therapeutic effect relate only to blood pressure decrease. The maximal hypotensive effect of cabergoline as a single dose usually occurs during the first 6 hours after drug intake and is dose-dependent both in terms of maximal decrease and frequency.

5.2 Pharmacokinetic properties

The pharmacokinetic and metabolic profiles of cabergoline have been studied in healthy volunteers of both sexesin female hyperprolactinemic patients and in parkinsonian patients. After oral administration of the labelled compound, radioactivity was rapidly absorbed from the gastrointestinal tract as the peak of radioactivity in plasma was between 0.5 and 4 hours. Ten days after administration about 18/20% and 55/72% of the radioactive dose (3H-cabergoline/14C-cabergoline) was recovered in urine and faeces, respectively. Unchanged drug in urine accounted for 2-3% of the dose.

In urine, the main metabolite identified was 6-allyl-8b-carboxy-ergoline, which accounted for 4-6% of the dose. Three additional metabolites were identified in urine, which accounted overall for less than 3% of the dose. The metabolites have been found to be much less potent than cabergoline as D2 dopamine receptor agonists in vitro.

The low urinary excretion of unchanged cabergoline has been confirmed also in studies with non-radioactive product. The elimination half-life of cabergoline, estimated from urinary excretion rates, is long (63-68 hours in healthy volunteers, 79-115 hours in hyperprolactinemic patients).

The pharmacokinetics of cabergoline seem to be dose-independent both in healthy volunteers (doses of 0.5-1.5 mg) and parkinsonian patients (steady state of daily doses up to 7 mg/day).

On the basis of the elimination half-life, steady state conditions should be achieved after 4 weeks, as confirmed by the mean peak plasma levels of cabergoline obtained after a single dose (37+8 pg/ml) and after a 4 week multiple-regimen (101+43 pg/ml). In vitro experiments showed that the drug at concentrations of 0.1-10 ng/ml is 41-42% bound to plasma proteins.

Food does not appear to affect absorption and disposition of cabergoline.

While renal insufficiency has been shown not to modify cabergoline kinetics, hepatic insufficiency of severe degree (> 10 Child-Pugh score, maximum score 12) has been shown to be associated with an increase of AUC.

5.3 Preclinical safety data

Almost all the findings noted throughout the series of preclinical safety studies are a consequence of the central dopaminergic effects or the long-lasting inhibition of PRL in rodents with a specific hormonal physiology different to man.

Preclinical safety studies of cabergoline indicate a consistent safety margin for this compound in rodents and in monkeys, as well as a lack of teratogenic, genotoxic or carcinogenic potential.

6.Pharmaceutical particulars

6.1 List of excipients

Lactose

Leucine

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 25 °C.

6.5 Nature and contents of container

Class I amber glass bottles, stoppered with an aluminium tamper-evident screw cap equipped with a low density polyethylene/thermoplastic elastomer (LDPE/TPE) plastic, undercap acting as a container holding silica gel, closed by a plastic cap with a porous paper at the lower extremity. Or

White, high-density polyethylene (HDPE) bottles with a child-resistant polypropylene (PP) cap equipped with inner low-density polyethylene (LDPE) desiccant canister containing silica gel.

Each bottle contains 20 or 30 tablets and is enclosed in an outer cardboard carton.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Bottles of Cabergoline are supplied with desiccant in the caps. This desiccant must not be removed.

7. 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

Cabergoline Tablets USP 0.5mg, 1mg, 2 mg Taj Pharma

Package leaflet: Information for the patient Cabergoline 0.5mg,1 mg and 2 mg Tablets cabergoline

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 Cabergoline is and what it is used for
  2. What you need to know before you take Cabergoline
  3. How to take Cabergoline
  4. Possible side effects
  5. How to store Cabergoline.
  6. Contents of the pack and other information

1.What Cabergoline is and what it is used for

Cabergoline contains the active substance cabergoline. This medicine belongs to a group of medicines called dopamine agonists.

This medicine is used to treat the symptoms of Parkinson’s disease in adults.

It is used after your doctor has tried other treatments that have not worked or for people who are already taking other medicines for this illness to help control other symptoms.

Cabergoline acts in a similar way to a chemical in the body called dopamine. Patients with Parkinson’s disease do not have enough of this chemical.

You must talk to a doctor or pharmacist if you do not feel better or if you feel worse.

2.What you need to know before you take Cabergoline

Do not take Cabergoline:

If you are allergic to cabergoline, to other medicines called ergot alkaloids or any of the other ingredients of this medicine (listed in section 6).

If you will be treated with Cabergoline for a long period and have or had fibrotic disorders (scar tissue) affecting your heart valves.

If you have been told you have a problem affecting your heart valves.

If you have a history of abdominal, respiratory or cardiac fibrotic (scar tissue) disorders.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cabergoline if you have or had any of the following conditions:

Heart disease

Raynaud’s syndrome (causing cold hands and feet)

Severe chest problems (such as pleurisy)

Liver disease

Stomach ulcer, or bleeding from the stomach and intestines

Mental illness, in particular psychotic disorders

Fibrotic reactions (scar tissue) affecting your heart, lungs or abdomen. In case you are treated with Cabergoline for a long period, your physician will perform checks of your heart, lungs, kidneys and blood to determine if this medicine is suitable for you. An echocardiogram (an ultrasound test of the heart) will be taken before treatment is started and at regular intervals during treatment. If fibrotic reactions occur treatment will have to be discontinued.

Low blood pressure (postural hypotension) can occur following administration of this medicine, particularly during the first few days. Care should be taken when taking Cabergoline with other drugs known to lower blood pressure.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Other medicines and Cabergoline

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

The effectiveness of Cabergoline can be reduced by some medicines, these include:

Drugs used to treat mental illness (e.g. phenothiazines, butyrophenones, thioxanthenes)

Drugs used to treat sickness (e.g. metoclopramide)

Side-effects may be increased by other medicines, these include:

Antibiotics (e.g. erythromycin)

Drugs used for migraines (e.g. ergotamine)

Cabergoline with food and drink

See section 3 ‘How to take Cabergoline’.

Pregnancy, breast-feeding and fertility Pregnancy

You are advised to use adequate contraception while you are taking this medicine.

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

Breast-feeding

Tell your doctor if you are breast-feeding. You should not breast-feed while taking this medicine as this medicine may affect milk production (lactation). If you need to take Cabergoline you should use another method of feeding your baby.

Driving and using machines

Cabergoline can cause drowsiness (somnolence) and sudden sleepy episodes, in some cases without any warning signs or awareness. Do not drive, use any tools or machines or engage in activities requiring mental alertness or coordination if you experience these symptoms until they have resolved completely.

Cabergoline contains lactose

Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.How to take Cabergoline

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 usual starting dose of Cabergoline is 1 mg daily, preferably taken after food to reduce the side- effects. Your doctor may then increase the dose until he finds a suitable dose to control your symptoms. Cabergoline should be taken as a single daily dose. You should not take more than 3 mg of this medicine in one day.

If you take more Cabergoline than you should

If you take too many tablets, contact your doctor immediately or go to the nearest hospital A&E department. Symptoms of overdose may include nausea, vomiting, gastric complaints, low blood pressure when standing, confusion/psychosis or hallucinations.

If you forget to take Cabergoline

If you forget to take your medicine at the usual time, take it as soon as you remember then continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cabergoline

Your doctor will advise you how long to take Cabergoline. Your condition may return if you stop taking Cabergoline before you are advised.

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

4.Possible side effects

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

Tell your doctor immediately if you experience any of the following symptoms. These symptoms can be severe:

Very common side effect: may affect more than 1 in 10 people: heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion). The early symptoms may be one or more of the following: difficulty breathing, shortness of breath, palpitations (pounding heart), feeling faint, chest pain, back pain, pelvic pain or swollen legs. These may be the first signs of a condition called fibrosis, which can affect the lungs, heart/heart valves or back.

You may experience the following side effects:

Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

Strong impulse to gamble excessively despite serious personal or family consequences

Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

Uncontrollable excessive shopping or spending

Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

Other side-effects that may occur are:

Very common: may affect more than 1 in 10 people: Feeling sick (nausea), swelling of the feet and ankles due to accumulation of fluid in the tissues

Common: may affect up to 1 in 10 people: Being sick (vomiting), indigestion, stomach pain, inflamed stomach lining, constipation, involuntary or uncontrolled movements of the limbs, low blood pressure, sudden drop in blood pressure on standing, hallucinations, sleep disturbances, increased libido, confusion, headache, dizziness, drowsiness, vertigo, lack of bodily strength, weakness, chest pain (angina), difficulty breathing, abnormal blood tests for liver function, decreased haemoglobin and/or red blood cells

Uncommon: may affect up to 1 in 100 people: Hypersensitivity reactions, rash, severe burning pain and skin redness in the hands and feet, swelling due to accumulation of fluid in the tissues (oedema), muscle spasms, fatigue, delusions, psychotic disorder, abnormal liver function

Not known: frequency cannot be estimated from the available data: Respiratory disorder, respiratory failure, pleuritis (inflammation of the linings around the lungs), chest pain, abnormal vision, suddenly falling asleep, fainting, tremor, aggressive behaviour, hair loss, leg cramps, cold hands and feet, an increase in the level of some enzymes in the blood

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. You can also report side effects directly.

5.How to store Cabergoline

Keep this medicine out of the sight and reach of children. Do not store above 25 °C.

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

Cabergoline tablets absorb moisture, so you should always replace the cap after taking out your tablets. Do not remove the special granules from the cap, and do not transfer your tablets to another container.

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.

6.Contents of the pack and other information

What Cabergoline contains

The active substance is cabergoline. Each tablet contains 0.5mg, 1 mg or 2 mg cabergoline.

The other ingredients are lactose and leucine (see section 2 ‘Cabergoline contains lactose’).
What Cabergoline looks like and contents of the pack

Cabergoline tablets are white, oval and both sides concave 0.5mg, 1 mg tablets and 2 mg tablets.

The tablets are contained in either amber glass bottles with an aluminium tamper-evident screw cap or white, high-density polyethylene bottles with a child-resistant polypropylene cap. The caps of both bottles contain a silica gel insert.

Each bottle contains 20 or 30 tablets and is enclosed in an outer cardboard carton.

Not all pack sizes may be marketed.

7. 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

 

 

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