BACLOFEN 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. BACLOFEN POLPHARMA, 10 mg, tablets
3. BACLOFEN POLPHARMA, 25 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Baclofen Polpharma and what is it used for
5. Important information before taking Baclofen Polpharma
   1. When not to take Baclofen Polpharma:
   2. Warnings and precautions
   3. Use in children and adolescents
   4. Baclofen Polpharma and other medicines
   5. Baclofen Polpharma with food, drinks, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Baclofen Polpharma contains lactose monohydrate
6. How to take Baclofen Polpharma
   1. Adults
   2. Children and adolescents under 18 years of age
   3. Taking a higher dose of Baclofen Polpharma than recommended
   4. Missing a dose of Baclofen Polpharma
   5. Stopping treatment with Baclofen Polpharma
7. Possible side effects
   1. Immediately consult a doctor if you notice the following
   2. Reporting side effects
8. How to store Baclofen Polpharma
9. Contents of the pack and other information
   1. What Baclofen Polpharma contains
   2. What Baclofen Polpharma looks like and contents of the pack
   3. Pack contains 50 or 100 tablets.
   4. Marketing authorization holder and manufacturer
   5. Marketing authorization holder
   6. Manufacturer
   7. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

BACLOFEN POLPHARMA, 10 mg, tablets

BACLOFEN POLPHARMA, 25 mg, tablets

Baclofen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Baclofen Polpharma and what is it used for
• 2. Important information before taking Baclofen Polpharma
• 3. How to take Baclofen Polpharma
• 4. Possible side effects
• 5. How to store Baclofen Polpharma
• 6. Contents of the pack and other information

1. What is Baclofen Polpharma and what is it used for

Baclofen Polpharma is a muscle relaxant used in adults and children. The medicine is used to reduce and alleviate excessive tension of skeletal muscles (spasms) that occur in various disease states, such as cerebral palsy, multiple sclerosis, brain strokes, spinal cord damage, and other nervous system diseases. It reduces pain associated with excessive muscle tension and facilitates rehabilitation.

2. Important information before taking Baclofen Polpharma

When not to take Baclofen Polpharma:

• if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6);
• if you have stomach or duodenal ulcer disease.

Warnings and precautions

Before starting treatment with Baclofen Polpharma, discuss it with your doctor. You should be particularly careful when taking Baclofen Polpharma:

• if you have kidney or liver function disorders;
• if you are over 65 years old;
• if you have a mental illness (e.g. psychotic disorders, schizophrenia, confusion);
• if you have epilepsy or have had seizures in the past;
• if you need increased muscle tone to maintain an upright body position and balance or to increase the range of motion;
• if you have recently had a brain stroke;
• if you have respiratory system disorders;
• if you have increased bladder sphincter tone;
• if you have a history of alcoholism, currently drink excessively, or have a history of substance abuse or dependence.

Some people treated with baclofen have had thoughts of self-harm or suicide, or have attempted suicide. Most of these people also had depression, excessive alcohol consumption, or a tendency to have suicidal thoughts. If you have ever had thoughts of self-harm or suicide, you should immediately consult a doctor or go to the hospital. You should also ask a relative or close friend to read this leaflet and pay attention to any worrying changes in your behavior. In some patients taking Baclofen Polpharma at the recommended doses, there was a reduction in brain function (encephalopathy), which disappeared after the medicine was discontinued. Symptoms include increased drowsiness, disorientation, muscle spasms, or coma. If any of these symptoms occur, you should immediately seek medical attention. The doctor will decide whether to discontinue baclofen. Before a planned surgical procedure, inform the surgeon that you are taking Baclofen Polpharma.

Use in children and adolescents

The medicine in the form of tablets should not be given to children with a body weight below 33 kilograms.

Baclofen Polpharma and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, especially:

• antidepressants, such as clomipramine, amitriptyline
• lithium salts (used to treat certain mental illnesses)
• blood pressure lowering medicines (the doctor will recommend monitoring blood pressure while taking these medicines with baclofen)
• ibuprofen (used for pain and arthritis)
• levodopa with carbidopa (a medicine used for Parkinson's disease).

Baclofen Polpharma with food, drinks, and alcohol

See section 3. Baclofen Polpharma may enhance the sedative effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. Baclofen Polpharma may only be used in pregnant women when, in the doctor's opinion, it is absolutely necessary. The active substance of the medicine, baclofen, passes into breast milk, so breastfeeding is not recommended while taking the medicine.

Driving and using machines

Do not drive vehicles or operate machines if you experience side effects that may affect your psychophysical fitness, such as drowsiness, sedation, or fatigue.

Baclofen Polpharma contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Baclofen Polpharma

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. The dose of the medicine is determined by the doctor, taking into account the patient's condition.

Adults

It is usually recommended to start treatment with a dose of 5 mg (½ of a 10 mg tablet) 3 times a day and gradually increase the dose every 3 days until the desired therapeutic effect is achieved. In most patients, the expected efficacy occurs at a dose of 30 mg to 75 mg per day. In patients who require higher doses of the medicine (75 mg to 100 mg per day), baclofen can be taken in the form of 25 mg tablets. Do not take more than 100 mg per day.

Children and adolescents under 18 years of age

Treatment in children should be adjusted according to the child's body weight. Treatment in children should be started with a very small dose (about 0.3 mg/kg body weight per day), in 2-4 divided doses (preferably in 4 divided doses). The dose should be gradually increased until the desired therapeutic effect is achieved in the child. The usual daily maintenance dose is from 0.75 to 2 mg/kg body weight. The maximum daily dose should not exceed 40 mg in children under 8 years of age. In children over 8 years of age, the maximum daily dose is 60 mg. The medicine should be taken during meals.

Taking a higher dose of Baclofen Polpharma than recommended

In case of overdose, immediately consult a doctor or go to the emergency room of the nearest hospital. After an overdose, the following side effects may occur: drowsiness, loss of consciousness, coma, respiratory depression. You may also experience: confusion, hallucinations, agitation, vision disturbances, decreased muscle tone, sudden muscle spasms, weakness or lack of reflexes, seizures, peripheral vasodilation, low or high blood pressure, heart rhythm disturbances (slow, fast, or irregular heartbeat), changes in the ECG, decreased body temperature, nausea, vomiting, diarrhea, excessive salivation, increased liver enzyme activity in blood tests, muscle pain, and dark urine color (rhabdomyolysis), ringing in the ears.

Missing a dose of Baclofen Polpharma

If you miss a dose, take it as soon as possible. However, if it is close to the time of the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Baclofen Polpharma

Do not suddenly stop treatment or change the dosage without consulting your doctor first. The dose of Baclofen Polpharma should be gradually reduced over a period of 1-2 weeks. Suddenly stopping treatment with Baclofen Polpharma is associated with a risk of side effects, such as seizures, anxiety, fear, hallucinations, mood disturbances, and mental disorders, increased muscle tone, mood disturbances. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

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

Immediately consult a doctor if you notice the following

symptoms:chest pain, shortness of breath, fainting, hematuria, depression, confusion, hallucinations, skin rash, seizures, vision disturbances, significant muscle weakness, vomiting. The following is a list of side effects that have occurred in patients taking medicines containing baclofen: Very common side effects (occurring in more than 1 in 10 patients): drowsiness, sedation, confusion, nausea. Common side effects (occurring in less than 1 in 10 patients): weakness, fatigue, exhaustion, low body temperature, shallow and slow breathing, feeling of emptiness in the head, headaches and dizziness, ataxia (lack of coordination), insomnia, disorientation, dry mouth, taste disturbances, anorexia, nausea, vomiting, constipation, diarrhea, low blood pressure, muscle weakness, muscle pain, tremors, rash, excessive sweating, increased urine production, involuntary or painful urination. Rare side effects (occurring in less than 1 in 1000 patients): tingling and numbness in the limbs (paresthesia), speech impairment, euphoria, agitation, depression, hallucinations, nightmares, lowered seizure threshold and increased number of seizures (especially in patients with epilepsy), abdominal pain, liver function disorders, chest pain, palpitations, shortness of breath, fainting, swelling of the ankles, nocturia, urinary retention, hematuria, impotence, ejaculation disorders, respiratory depression. Frequency not known (frequency cannot be estimated from the available data): weight gain, difficulty breathing during sleep (sleep apnea syndrome), reduction in brain function (encephalopathy), feeling of nasal congestion, positive result of the occult blood test in stool, itching. In some patients, an intensification of spastic states (paradoxical reaction to the medicine) has been observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring 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 authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Baclofen Polpharma

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package to protect from light and moisture. Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Baclofen Polpharma contains

• The active substance is baclofen. Each tablet contains 10 mg or 25 mg of baclofen.
• The other ingredients are: lactose monohydrate, potato starch, gelatin, talc, magnesium stearate, ethyl cellulose.

What Baclofen Polpharma looks like and contents of the pack

Baclofen Polpharma 10 mg are white, round, biconvex tablets with a dividing line. The tablet can be divided into equal doses. Baclofen Polpharma 25 mg are white, round, biconvex tablets.

Pack contains 50 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, Zakłady Farmaceutyczne POLPHARMA S.A., Oddział Medana w Sieradzu, ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: