Baclofix^®

Baclofix® is a muscle relaxant that reduces muscle spasticity by inhibiting the transmission of certain reflexes and nerve impulses within the central nervous system.

• Relief of muscle spasticity
• Treatment of hiccups
• Adjunctive treatment for muscle pain
• Adjunctive treatment of alcohol use disorder

10 mg Oral Tablets

• Take Baclofix® exactly as prescribed by your physician or pharmacist.
• To achieve the best therapeutic response, do not alter the dose or duration of treatment without medical advice.
• Take Baclofix® at the same time each day, with or without food.

If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses simultaneously or an additional dose to make up for a missed dose.

If more than the prescribed dose is taken, contact your physician immediately or seek emergency medical attention.

• Electroencephalogram (EEG) monitoring in patients with epilepsy
• Signs and symptoms of Baclofen withdrawal
• Signs of overdose, including confusion, drowsiness, and respiratory symptoms

• Hypersensitivity to Baclofen or any component of the formulation

• Baclofen may cause drowsiness or dizziness. Avoid driving, operating heavy machinery, or engaging in activities requiring mental alertness until you know how the medication affects you.
• If you have any type of urinary tract obstruction, inform your physician before starting treatment.
• Baclofen should be used with caution in patients with peptic ulcer disease, decreased gastrointestinal motility, or gastrointestinal obstructive disorders. Inform your physician if you have a history of any of these conditions.
• Use Baclofen cautiously in patients with psychiatric disorders, renal impairment, or respiratory diseases. Inform your physician if any of these conditions apply to you.
• Patients with a history of seizures should be monitored carefully during treatment. Inform your physician if you have previously experienced seizures.
• Elderly patients may be more sensitive to the adverse effects of Baclofen, particularly at higher doses; therefore, additional caution is advised in this population.
• Baclofen is not recommended for the treatment of muscle spasticity associated with rheumatoid arthritis. Inform your physician if you have a history of rheumatoid arthritis.
• Baclofen should not be discontinued abruptly. Consult your physician before stopping treatment.

• If treatment with Baclofen is required during pregnancy or breastfeeding, consult your physician.
• The use of Baclofen during pregnancy and lactation should be based on medical advice after careful consideration of the potential benefits and risks.

Like all medicines, Baclofix® may cause side effects, although not everybody experiences them. Possible adverse reactions include:

• Dizziness or drowsiness
• Fatigue
• Gastrointestinal disturbances, including nausea and vomiting

Consult your physician or pharmacist before taking Baclofen concomitantly with any other medications or dietary supplements.

Each package contains 100 Baclofen tablets (10 blister packs of 10 tablets each).

• Store below 30°C, protected from light and moisture.
• The product may be used until the last day of the month indicated as the expiration date on the package.
• Do not use or store expired medicines.
• Keep out of the reach of children.
• Do not remove the medication from its original packaging until ready for use.

1. Baclofen: Drug Information, UpToDate, 2025.
2. Electronic Medicines Compendium (Baclofen SmPC)