Zoloft

Package leaflet: Information for the user

ZOLOFT, 50 mg, film-coated tablets
ZOLOFT, 100 mg, film-coated tablets
Sertraline
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Zoloft is and what it is used for

Zoloft contains the active substance sertraline. Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines are used to treat depression and (or) anxiety disorders.
Zoloft may be used to treat:

• depression and to prevent recurrence of depression (in adults),
• social anxiety disorder (in adults),
• post-traumatic stress disorder (PTSD) (in adults),
• panic disorder (in adults),
• obsessive-compulsive disorder (OCD) (in adults and in children and adolescents aged 6–17 years).

Depression is a condition characterized by symptoms such as sadness, difficulty sleeping, or loss of interest or pleasure in life.
Obsessive-compulsive disorder and panic disorder are anxiety-related conditions, associated with persistent anxiety due to intrusive thoughts (obsessions), which lead to repetitive rituals (compulsions).
Post-traumatic stress disorder (PTSD) is a condition that may occur after experiencing a very traumatic event and is characterized by symptoms similar to depression and anxiety. Social anxiety disorder (social phobia) is an anxiety disorder characterized by marked fear or anxiety in social situations (such as talking to strangers, speaking in front of a group of people, eating or drinking in the presence of others, or fear of potentially embarrassing behavior).
Your doctor has decided that this medicine is suitable for treating your condition. You should consult your doctor if you are unsure why you are taking Zoloft.

2. Important information before using Zoloft

When not to use Zoloft:

• if the patient is allergic to sertraline or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking or has recently taken monoamine oxidase inhibitors (MAO inhibitors, e.g. selegiline, moclobemide), or medicines similar to MAO inhibitors (e.g. linezolid). After stopping treatment with sertraline, at least one week must elapse before starting treatment with an MAO inhibitor. After stopping treatment with an MAO inhibitor, at least two weeks must elapse before starting treatment with sertraline;
• if the patient is taking pimozide (a medicine used in psychiatric disorders such as psychosis).

Warnings and precautions
Before starting to take Zoloft, discuss this with your doctor or pharmacist.
Medicines are not always suitable for everyone. Tell your doctor before taking Zoloft if any of the following apply to you currently or have applied in the past:

• Epilepsy (seizures) or previous history of seizures. If a seizure occurs, contact your doctor immediately.
• Previous history of bipolar disorder (manic depression) or schizophrenia. If a manic episode occurs, contact your doctor immediately.
• Current or previous thoughts of self-harm or suicide (see below – Suicidal thoughts, worsening depression or anxiety).
• Serotonin syndrome. In rare cases, this syndrome may occur in patients taking sertraline together with certain other medicines. (Symptoms, see section 4. Possible side effects). Your doctor should ask if you have ever experienced serotonin syndrome in the past.
• Low sodium blood levels, which may occur as a result of taking Zoloft. You should also inform your doctor if you are taking medicines used to treat high blood pressure, as they may also affect sodium levels in the blood.
• Elderly patients: the risk of low sodium blood levels (see above) is higher in this group.
• Liver disease: your doctor may decide to reduce the dose of Zoloft.
• Diabetes: Zoloft may affect blood glucose levels, so it may be necessary to adjust the dose of antidiabetic medicines.
• History of bleeding disorders (tendency to bruise) or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”), and also previous use of medicines that prevent blood clotting [e.g. acetylsalicylic acid (aspirin) or warfarin] or that may increase the risk of bleeding.
• Children or adolescents under 18 years of age. Zoloft may be used in children and adolescents aged 6 to 17 years only for the treatment of obsessive-compulsive disorder (OCD). Patients being treated for this condition should be closely monitored by a doctor (see below – Children and adolescents).
• Electroconvulsive therapy (ECT) is being administered.
• Eye problems, such as certain types of glaucoma (increased pressure in the eye).
• Abnormalities on ECG, known as prolonged QT interval.
• Heart disease, low potassium or magnesium levels, prolonged QT interval in any family member, slow heart rate, and concomitant use of medicines that cause QT prolongation.

Psychomotor agitation/Akathisia:
Sertraline has been associated with the development of a condition characterised by motor restlessness and a compelling need to move – often with inability to sit still or remain motionless (akathisia). This condition usually occurs within the first few weeks of treatment. Contact your doctor if the dose is increased, as this may be harmful in patients experiencing such symptoms.
Withdrawal symptoms:
After stopping treatment, unwanted effects (withdrawal symptoms) often occur, especially if treatment was stopped abruptly (see section 3. Stopping Zoloft and section 4. Possible side effects). The risk of withdrawal symptoms depends on the duration of treatment, dose, and rate of dose reduction. These symptoms are generally mild or moderate in intensity, but may be severe in some patients. They usually occur within the first few days after stopping treatment. They usually resolve spontaneously within 2 weeks, but may persist longer in some patients (for 2–3 months or longer). If a decision is made to discontinue sertraline treatment, gradual dose reduction over several weeks or months is recommended, and you should consult your doctor on the best way to stop treatment.
Suicidal thoughts, worsening depression or anxiety:
People who have depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually take about 2 weeks, or sometimes longer, to start working.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously had suicidal thoughts or a desire to self-harm;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are being treated with antidepressants. If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to hospital.

It may be helpful to inform family members or friends about the depression or anxiety disorder, and ask them to read this leaflet. The patient may ask family or friends for help and ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behaviour.
Sexual dysfunction
Medicines such as Zoloft (so-called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
Children and adolescents:
Sertraline should generally not be used in children and adolescents under 18 years of age, except for patients with obsessive-compulsive disorder (OCD). In patients under 18 years of age, an increased risk of adverse reactions such as suicide attempts, thoughts of self-harm or suicide (suicidal thoughts), and hostility (mainly aggressive, defiant and angry behaviour) has been observed during treatment with medicines of this class. However, your doctor may decide to prescribe Zoloft to a patient under 18 years of age if it is in the patient's best interest. If your doctor prescribes Zoloft to a patient under 18 years of age and the child's caregiver wishes to discuss this, contact the doctor.
Furthermore, if any of the symptoms listed above appear or worsen during treatment with Zoloft, inform your doctor.
In a long-term observational study lasting 3 years involving over 900 children aged 6 to 16 years, the long-term safety of Zoloft was evaluated with regard to its effects on growth, maturation, learning (cognitive functions), and behaviour. Overall, study results showed that children treated with sertraline developed normally, except for a small reduction in weight gain in children treated with higher doses.
Zoloft and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may affect how Zoloft works, or Zoloft itself may reduce the effectiveness of other medicines taken at the same time.
Taking Zoloft together with the following medicines may cause serious side effects:

• Monoamine oxidase inhibitor (MAO) medicines, e.g. moclobemide (used to treat depression), selegiline (used to treat Parkinson's disease), the antibiotic linezolid, and methylene blue (used to treat high levels of methemoglobin in the blood). Do not take Zoloft together with these medicines.
• Medicines used to treat psychiatric disorders such as psychosis (pimozide). Do not take Zoloft together with pimozide.

You should inform your doctor if you are taking the following medicines:

• Medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), excessive sleepiness and obesity).
• Herbal medicines containing St. John's wort (Hypericum perforatum). The effect of St. John's wort may persist for 1–2 weeks.
• Preparations containing the amino acid tryptophan.
• Medicines used to treat severe or chronic pain (opioids, e.g. tramadol, fentanyl).
• Medicines used in anaesthesia (e.g. fentanyl, mivacurium and suxamethonium).
• Medicines used to treat migraine (e.g. sumatriptan).
• Medicines that prevent blood clotting (warfarin).
• Medicines used to treat joint pain/inflammation [e.g. metamizole, non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, acetylsalicylic acid (aspirin)].
• Sedatives (diazepam).
• Diuretics (so-called water tablets).
• Medicines used to treat epilepsy (phenytoin, phenobarbital, carbamazepine).
• Medicines used to treat diabetes (tolbutamide).
• Medicines used to treat excessive stomach acid, peptic ulcer disease and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole).
• Medicines used to treat mania and depression (lithium).
• Other medicines used to treat depression (such as amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine).
• Medicines used to treat schizophrenia and other psychiatric disorders (such as perphenazine, levomepromazine and olanzapine).
• Medicines used to treat high blood pressure, chest pain or to regulate heart rate and rhythm (such as verapamil, diltiazem, flecainide, propafenone).
• Medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin).
• Medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole).
• Medicines used to treat HIV/AIDS and hepatitis C (protease inhibitors, such as ritonavir, telaprevir).
• Medicines used to prevent nausea and vomiting after chemotherapy (aprepitant).
• Medicines that increase the risk of changes in the heart's electrical activity (e.g. antipsychotics and antibiotics).

Taking Zoloft with food, drink and alcohol:
Zoloft tablets can be taken with or without food.
During treatment with Zoloft, do not consume alcohol.
Do not take Zoloft together with grapefruit juice, as this may lead to increased levels of sertraline in the body.
Pregnancy, breastfeeding and fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
The safety of sertraline use in pregnant women has not been fully established. The medicine may be used in pregnant women only if, in the doctor's opinion, the benefits to the mother outweigh the potential risks to the developing child.
Taking Zoloft late in pregnancy may increase the risk of serious vaginal bleeding shortly after childbirth, especially if the patient has a history of bleeding disorders. If you are taking Zoloft, inform your doctor or midwife so they can provide appropriate advice. Use of medicines such as Zoloft during pregnancy, particularly in the third trimester, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), characterised by rapid breathing and bluish skin in the baby. These symptoms usually appear within the first day of life. If the baby shows any of these symptoms, contact your midwife or doctor immediately.
Other complications may also occur in the newborn, which usually appear within the first 24 hours after birth. Symptoms include:

• breathing difficulties,
• bluish or pale skin, skin that is too hot or too cold,
• blue lips,
• vomiting or feeding difficulties,
• excessive tiredness, trouble sleeping or constant crying,
• increased or decreased muscle tone,
• tremors, muscle twitches or seizures,
• increased reflexes,
• irritability,
• low blood sugar.

If any of these symptoms occur in the baby after birth or if the baby's health is concerning, contact your doctor or midwife.
There is evidence that sertraline passes into human milk. The medicine may be used in breastfeeding women if, in the doctor's opinion, the benefits outweigh the potential risks to the infant.
Animal studies have shown that some medicines similar to sertraline reduced semen quality. This could theoretically affect fertility, although no effect on fertility has been observed in humans to date.
Driving and operating machinery:
Psychotropic medicines such as sertraline may affect the ability to drive or operate machinery. Wait until you know how Zoloft affects your ability before performing these activities.
Zoloft contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Zoloft

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Recommended dosage of Zoloft:
Adults:
Depression and obsessive-compulsive disorder (OCD):
The usual effective dose in the treatment of depression and OCD is 50 mg per day.
The daily dose may be gradually increased by 50 mg at intervals of at least one week over several weeks. The maximum recommended dose is 200 mg per day.
Panic disorder, social anxiety disorder, and post-traumatic stress disorder:
Treatment of panic disorder, social anxiety disorder, and post-traumatic stress disorder should be initiated at a dose of 25 mg per day, increasing after one week to 50 mg per day.
The daily dose may then be gradually increased by 50 mg at a time over several weeks. The maximum recommended dose is 200 mg per day.
Use in children and adolescents:
Zoloft may be used in the treatment of children and adolescents aged 6–17 years only for obsessive-compulsive disorder (OCD).
Obsessive-compulsive disorder (OCD):
Children aged 6 to 12 years: The recommended starting dose is 25 mg per day. After one week, the doctor may increase the dose to 50 mg per day. The maximum dose is 200 mg per day.
Adolescents aged 13 to 17 years: The recommended starting dose is 50 mg per day. The maximum dose is 200 mg per day.
Patients with liver or kidney disease should inform their doctor and follow medical advice.
Method of administration:
Zoloft tablets may be taken with or without food.
The medicine should be taken once daily, in the morning or evening.
Your doctor will inform you how long you should continue treatment. The duration of treatment depends on the type of illness and your individual response to therapy. Improvement may take several weeks. Treatment of depression should usually continue for 6 months after improvement occurs.
Taking more Zoloft than recommended:
If you accidentally take too much Zoloft, contact your doctor immediately or go to the nearest hospital emergency department. Always bring the medicine package and the label with you, regardless of whether any medicine remains.
Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heartbeat, muscle tremors, agitation, dizziness, and in rare cases, loss of consciousness.
If you miss a dose of Zoloft:
Do not take a double dose to make up for a missed dose.
If you forget to take a tablet, do not take the missed tablet. Simply take the next tablet at the usual time.
Stopping Zoloft:
You must not stop taking Zoloft on your own. Your doctor should gradually reduce the dose of Zoloft over several weeks until you finally stop taking it completely.
If you stop taking Zoloft suddenly, you may experience adverse effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting, and muscle tremors.
If you experience any of these or other adverse effects after stopping Zoloft, consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most commonly occurring side effect is nausea. Side effects depend on
the dose and often diminish or weaken as treatment continues.
You should contact your doctor immediately
If any of the following symptoms occur in the patient after taking this medicine, as
they may be serious.

• If the patient develops a severe skin rash causing blisters to form (erythema multiforme; blisters may appear in the mouth and on the tongue). These may be symptoms of a condition called Stevens-Johnson syndrome or toxic epidermal necrolysis. In such cases, the doctor will discontinue treatment.
• Allergic reaction or allergy, with symptoms such as: itchy skin rash, breathing difficulties, wheezing, eyelid, facial or lip swelling.
• If the patient experiences: agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat. These are symptoms of serotonin syndrome. In rare cases, this syndrome may occur when the patient is taking certain medicines at the same time as sertraline. The doctor may then discontinue the patient's treatment.
• If the patient develops yellowing of the skin and eyes, which may indicate liver damage.
• If the patient experiences symptoms of depression with thoughts of self-harm or suicide (suicidal thoughts).
• If, after starting treatment with Zoloft, the patient begins to feel inner restlessness and is unable to sit or stand still. If the patient experiences such restlessness, they should inform their doctor.
• If the patient has a seizure (epileptic fit).
• If the patient experiences manic episodes (see section 2. Warnings and precautions).

The following side effects have been observed in clinical trials and after marketing of the medicine in adult patients.
Very common (may affect more than 1 in 10 people):
insomnia, dizziness, somnolence, headache, diarrhoea, nausea, dry mouth,
ejaculation disorders, fatigue.
Common (may affect up to 1 in 10 people):

• bronchitis, sore throat, nasal congestion,
• loss of appetite, increased appetite,
• anxiety, depression, agitation, decreased interest in sex, nervousness, strange feelings, nightmares, teeth grinding,
• muscle tremors, movement disorders (such as increased motor activity, increased muscle tension, difficulty walking, muscle stiffness, cramps and involuntary muscle movements), numbness and tingling, increased muscle tension, lack of concentration, taste disturbances,
• visual disturbances,
• tinnitus,
• palpitations,
• hot flushes,
• yawning,
• gastric discomfort, constipation, abdominal pain, vomiting, flatulence,
• increased sweating, rash,
• back pain, joint pain, muscle pain,
• irregular menstruation, erection disorders,
• malaise, chest pain, weakness, fever,
• weight gain,
• injuries.

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

• intestinal disorders, ear infection,
• tumour,
• hypersensitivity, seasonal allergy,
• decreased thyroid hormone levels,
• suicidal thoughts, suicidal behaviour, psychotic disorders, thought disturbances, emotional blunting, hallucinations, aggression, feeling of euphoria, delusions,
• memory impairment, reduced sensation, involuntary muscle contractions, loss of consciousness, increased motor activity, migraine, seizures, dizziness upon standing, coordination disorders, speech disorders,
• pupil dilation,
• ear pain,
• increased heart rate, heart problems,
• haemorrhagic disorders (including gastrointestinal bleeding), high blood pressure, sudden skin redness, blood in urine,
• shortness of breath, nosebleeds, breathing difficulties, wheezing,
• tarry stools, dental disorders, oesophagitis, tongue problems, haemorrhoids, increased salivation, difficulty swallowing, belching, tongue disorders,
• eye swelling, urticaria, hair loss, itching, purpuric skin spots, blistering skin disorders, dry skin, facial swelling, cold sweats,
• degenerative joint disease, muscle tics, painful muscle cramps, muscle weakness,
• increased frequency of urination, urinary problems, inability to urinate, urinary incontinence, increased urine output, nocturnal urination,
• sexual disorders, excessive vaginal bleeding, vaginal haemorrhage, sexual disorders in women,
• leg swelling, chills, difficulty walking, excessive thirst,
• increased liver enzyme activity, weight loss.
• During treatment with sertraline or shortly after its discontinuation, cases of suicidal thoughts and behaviours have been reported (see section 2).

Rare (may affect up to 1 in 1000 people):

• diverticulitis, lymph node swelling, decreased platelet count, decreased white blood cell count,
• severe allergic reactions,
• endocrine disorders,
• high cholesterol levels, problems maintaining normal blood sugar levels (diabetes), low blood sugar, increased blood sugar, low blood sodium levels,
• physical symptoms caused by stress or emotions, nightmares, drug dependence, sleepwalking, premature ejaculation,
• stupor, abnormal movements, difficulty moving, increased sensory sensitivity, sudden severe headache (which may be a symptom of a serious condition called reversible cerebral vasoconstriction syndrome), sensory disturbances,
• spots before the eyes, glaucoma, double vision, light sensitivity, blood in the eye, unequal pupil size*, abnormal vision*, tear secretion disorders,
• myocardial infarction, feeling of impending fainting, fainting or chest discomfort, which may be symptoms of changes in the heart's electrical activity (visible on electrocardiogram) or irregular heartbeat, slowed heart rate,
• worsening of blood circulation in the upper and lower limbs,
• increased respiration rate, progressive pulmonary tissue fibrosis (interstitial lung disease), laryngospasm, difficulty speaking, slowed breathing, hiccups,
• a form of lung disease in which eosinophils (a type of white blood cell) appear in increased numbers in the lungs (eosinophilic pneumonia),
• oral ulceration, pancreatitis, presence of blood in stool, tongue ulceration, oral pain,
• liver function disorders, severe liver function disorders, yellowing of the skin and eyes (jaundice),
• skin reaction to sunlight, skin swelling, abnormal hair structure, abnormal skin odour, scalp rash,
• muscle tissue breakdown, bone disorders,
• difficulty initiating urination, reduced urine output,
• nipple discharge, vaginal dryness, genital discharge, painful red penis and foreskin, breast enlargement, prolonged penile erection,
• hernia, decreased drug tolerance,
• increased blood cholesterol levels, abnormal laboratory test results, abnormal semen analysis, blood clotting problems,
• vasodilatation.

Frequency not known (frequency cannot be estimated from available data):

• bruxism
• nocturnal enuresis
• partial loss of vision
• colitis (causing diarrhoea)
• severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2
• muscle weakness and severe muscle pain, which may be symptoms of a disorder resembling glutaric aciduria type II.

Side effects reported after marketing of the medicine
Additional side effects in children and adolescents:
In clinical trials involving children and adolescents, side effects were generally similar
to those occurring in adults (see above). The most commonly occurring side effects in children and adolescents were: headache, insomnia, diarrhoea and nausea.
Symptoms occurring after discontinuation:
After abrupt discontinuation of the medicine, side effects such as dizziness,
numbness, sleep disturbances, agitation or anxiety, headache, nausea, vomiting and muscle tremors
may occur (see section 3. Discontinuing treatment with Zoloft).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or its representative.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Zoloft

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Zoloft contains
Zoloft, coated tablets:
Zoloft 50 mg
Each coated tablet contains 50 mg of sertraline as sertraline hydrochloride.
Zoloft 100 mg
Each coated tablet contains 100 mg of sertraline as sertraline hydrochloride.
The other ingredients are:
dibasic calcium phosphate dihydrate (E341), microcrystalline cellulose (E460),
hydroxypropylcellulose (E463), sodium carboxymethylstarch (type A) (see section 2: "Zoloft contains sodium"),
magnesium stearate (E572), hypromellose 2910/3 mPas (E464), hypromellose 2910/6 mPas (E464),
titanium dioxide (E171), macrogol 400 (E1521), macrogol 8000 (E1521), and polysorbate 80 (E433).

What Zoloft looks like and contents of the pack
Zoloft, coated tablets:
Zoloft 50 mg: white, elongated (10.3 x 4.2 mm), film-coated tablets, divisible, with the imprint "ZLT 50" on one side and "VLE" on the other. The tablet can be divided into two equal parts.
Zoloft 100 mg: white, elongated (13.1 x 5.2 mm), film-coated tablets with the imprint "ZLT 100" on one side and "VLE" on the other.

The tablets are available in aluminium/PVC blisters containing 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 98, 100, 200, 294, 300 or 500 tablets, and in blisters containing 30x1.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturer:
Pfizer Manufacturing Deutschland GmbH, Mooswaldallee 1, 79108 Freiburg Im Breisgau, Germany

This medicine is authorized for marketing in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

For more detailed information about this medicine, please contact the local representative of the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
tel. 22 546 64 00