10 mg tablets and 25 mg tablets 
Baclofen

Read all of this leaflet carefully before you or your child start taking this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Baklofen Mylan is and what it is used for 
2. What you need to know before taking Baclofen Mylan 
3. How to take Baclofen Mylan 
4. Possible side effects 
5. How to store Baclofen Mylan 
6. Package contents and other information

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

Baclofen Mylan belongs to a group of medicines called muscle relaxants. It is used to reduce and relieve various types of spasticity (muscle cramps) in e.g. multiple sclerosis and other diseases or injuries of the spinal cord and brain.

The muscle-relaxing effect improves mobility and relieves pain.

Baclofen contained in Baclofen Mylan may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Baclofen Mylan

Do not take Baclofen Mylan

– if you are allergic to baclofen or any of the other ingredients of this medicine (see section 6).

Warnings and cautions

If you have or have had the following conditions, talk to your doctor, pharmacist, or nurse before using Baclofen Mylan:

  • Parkinson’s disease or mental illness accompanied by confusion or depression
  • epilepsy
  • acute pain in the stomach ( stomach ulcer ) or intestine
  • breathing difficulties
  • liver disease
  • stroke (stroke)
  • kidney disease (your doctor will decide if Baclofen Mylan is a suitable treatment for you)
  • difficulty throwing water
  • have been addicted to alcohol, drink too much alcohol, or if you have abused or been addicted to drugs

Some people treated with baclofen have had thoughts of harming themselves or committing suicide or have attempted suicide. Most of these people also had depression, had used too much alcohol, or were prone to thoughts of committing suicide. If you ever have thoughts of injuring yourself or committing suicide, talk to your doctor or a hospital immediately. Also, ask a family member or close friend to tell you if they are worried about any changes in your behavior and ask them to read this leaflet.

Baclofen Mylan can cause lowering of blood pressure, which should be considered when using antihypertensive drugs.

Treatment with Baclofen Mylan may in rare cases cause dry mouth (see section 4: Possible side effects ). Careful oral hygiene is important in this case and the teeth should be brushed with fluoride toothpaste twice daily.

Children and young people

Baclofen Mylan tablets are not suitable for use in children weighing less than 33 kg. The small doses administered to smaller children can only be given via oral solution (licensing).

Other medicines and Baclofen Mylan

The treatment effect may be affected if this medicine is taken at the same time as certain other medicines.

The treating physician, therefore, needs to be aware of such concomitant medication. This applies in particular to:

– medicines used to treat mood disorders such as antidepressants and lithium

– medicines that lower blood pressure et

– medicines that can affect the kidneys (eg medicines to treat joint inflammation or pain)

– drugs for the treatment of Parkinson’s disease

– medicines that have a depressant effect on the central nervous system (eg muscle relaxants)

Alcohol should be avoided during treatment with Baclofen Mylan as baclofen may potentiate the dampening effect of alcohol on the central nervous system.

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

Use of Baclofen Mylan with food and drink

The tablets should be taken with a meal or with a glass of milk liquid to counteract stomach upset.

Pregnancy and breastfeeding

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

If you use Baclofen Mylan during pregnancy, there is a risk that your baby will have seizures or other symptoms that may occur with sudden discontinuation of treatment shortly after delivery (see section: 3 If you stop taking Baclofen Mylan). Your doctor may need to give your newborn baby a small dose of Baclofen Mylan and gradually reduce the dose one to control and prevent the symptoms.

Baclofen passes into breast milk but is unlikely to affect breastfed infants.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

During treatment with Baclofen Mylan, dizziness, fatigue, drowsiness, and visual disturbances may occur, which may reduce the ability to react. This should be taken into account when sharper attention is required, eg when driving a car.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

Baclofen Mylan contains Lactose

How to take Baclofen Mylan

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults

Dose one should be increased gradually. The usual starting dose is 15 mg daily, divided into 2-4 dosing times, which are gradually increased at three-day intervals until the optimal effect is achieved. The usual maintenance dose for adults is 30-75 mg daily divided into 2-4 dosing sessions.

arn and adolescents (0 up to 18 years)

Dose one should be increased gradually. The usual starting dose is 15 mg daily, divided into 2-4 dosing times, which are gradually increased at three-day intervals until the optimal effect is achieved. The usual maintenance dose for adults is 30-75 mg daily divided into 2-4 dosing sessions.

The total daily dose should not exceed 40 mg/day in children under 8 years of age. In children over 8 years of age, a maximum of 60 mg/day can be given. Baclofen Mylan tablets are not suitable for children under 33 kg in body weight. The small doses administered to smaller children can only be given via oral solution (licensing).

The tablets should be taken with a meal and should be swallowed with liquid.

Tell your doctor if you have been treated for 6-8 weeks without improvement. Your doctor will decide if you should continue treatment with Baclofen Mylan.

Signs of overdose may appear stealthily or suddenly. The main symptoms are drowsiness, difficulty breathing, decreased level of consciousness, and unconsciousness ( coma ).

Other symptoms may include: feeling confused, hallucinations, severe anxiety, cramps, blurred vision, abnormal muscle weakness, sudden muscle contractions, weak or absent reflexes, high or low blood pressure, slow, fast or irregular heartbeat, low body temperature, nausea, vomiting or vomiting. excessive salivation, difficulty breathing during sleep (sleep apnea syndrome), muscle pain, fever and dark urine ( rhabdomyolysis ).

If you have kidney disease and have accidentally taken more tablets than your doctor prescribed, you may experience neurological symptoms of overdose (eg drowsiness, confusion, hallucinations).

If you forget to take Baclofen Mylan

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Baklofen Mylan

Do not stop treatment without talking to your doctor first. A sudden interruption can, especially after long-term treatment, cause e.g. hallucinations, anxiety and confusion, palpitations, muscle pain, fever, and dark urine.

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

4. Possible side effects

Like all medicines, Baclofen Mylan can cause side effects, although not everybody gets them.

Very common (may affect more than 1 user in 10 ): Drowsiness.

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

Fatigue, headache, dizziness, low blood pressure, nausea, vomiting, constipation, diarrhea, impaired respiratory function, confusion, difficulty falling asleep.

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

Sweating, weight gain, ankle edema (swelling due to fluid retention), skin rash, itching, muscle weakness, nightmares, frequent urination, sexual dysfunction.

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

Muscle pain, palpitations, chest pain, fainting spells, shortness of breath, epileptic seizures, and crawls, difficulty coordinating muscle movements, coordination difficulties, tremors, stiffness, abnormally increased muscle tension, slurred speech, increased spasticity, baldness, hallucinations, exhaustion) , difficulty urinating, involuntary urination, blurred vision, trembling involuntary movements of the eyeballs, squinting, pupillary reduction, dry mouth, elevated blood glucose levels, the elevation of certain liver values ​​in the blood.

Very rare

(may affect up to 1 in 10,000 people) Lowered body temperature.

Has been reported  (occurs in an unknown number of users):

Hives. Bradycardia. Difficulty breathing during sleep (sleep apnea syndrome).

Contact your doctor if symptoms other than those listed occur or if any of the listed symptoms persist or worsen.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Baklofen Mylan

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is baclofen 10 mg and 25 mg respectively.

The other ingredients are microcrystalline cellulose, lactose monohydrate 40 mg, and 60 mg respectively, sodium starch glycollate, anhydrous calcium hydrogen phosphate, magnesium stearate, anhydrous colloidal silica.

What the medicine looks like and the contents of the pack

10 mg: white, faceted tablets with a scoreline, diameter 7 mm, marked BN / 10 and G.

25 mg: white, faceted tablets with a scoreline, diameter 8 mm, marked BN / 25 and G.

10 mg: 50 tablets in a plastic jar, 100 tablets in a blister, 100 x 1 tablet in a pressure pack (unit dose), 200 tablets in a plastic jar.

25 mg: 100 tablets in a plastic jar, 100 x 1 tablets in a pressure pack (single dose).

Holder of approval for sale / Information is submitted by

Tel: 08-555 227 50

Email: inform@mylan.se

Manufacturer

McDermott Laboratories to Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

Muhammad Nadeem

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