10 mg & 25 mg Tablets
Baclofen
1. What Baklofen Alternova is and what it is used for
Baclofen Alternova belongs to a group of medicines called muscle relaxants. It is used to reduce and relieve various types of spasticity (muscle cramps) in, for example, multiple sclerosis and other diseases or injuries of the spinal cord and brain. The muscle-relaxing effect improves mobility and relieves pain.
The baclofen contained in Baclofen Alternova 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.
2. What you need to know before using Baclofen Alternova
Do not use Baclofen Alternova
- if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).
Children and young people
Baclofen Alternova tablets are not suitable for use in children weighing less than 33 kg.
Warnings and cautions
Talk to your doctor before using Baclofen Alternova if you have or have had:
- Parkinson’s disease or mental illness accompanied by confusion or depression
- epilepsy
- acute pain in the stomach ( stomach ulcer ) or intestine
- breathing difficulties
- kidney disease (your doctor will decide if Baklofen Alternova is a suitable treatment for you)
- liver disease
- stroke (stroke)
- difficulty throwing water
- have been addicted to alcohol, drink too much alcohol, or if you have abused or been addicted to drugs.
Baclofen Alternova can cause lowering of blood pressure, which should be considered when using antihypertensive drugs.
Treatment with Baclofen Alternova may in rare cases cause dry mouth (see Side Effects ). Careful oral hygiene should be observed and the teeth should be brushed with fluoride toothpaste twice daily.
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.
Other medicines and Baclofen Alternova
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 depression (such as antidepressants and lithium)
- drugs that lower blood pressure et
- medicines that can affect the kidneys (for example medicines to treat arthritis or pain)
- drugs for the treatment of Parkinson’s disease
- drugs that have a dampening effect on the central nervous system (for example, muscle relaxants)
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Baclofen Alternova with food, drink, and alcohol
The tablets should be taken with a meal or with a glass of milk to counteract stomach upset.
Alcohol should be avoided during treatment with Baclofen Alternova as baclofen may enhance the dampening effect of alcohol on the central nervous system.
Pregnancy and breastfeeding
If you are pregnant, do not take Baclofen Alternova, unless your doctor thinks it is absolutely necessary. If you use Baclofen Alternova during pregnancy, there is a risk that your baby will have seizures shortly after giving birth.
If you think you may be pregnant, ask your doctor or pharmacist for advice before taking Baclofen Alternova.
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 Alternova, 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.
How to use Baklofen Alternova
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Usual dose
Adults
The treatment should be started insidiously to avoid side effects. The usual starting dose is 15 mg daily, divided into 2-4 doses. The dose is gradually increased to 30-75 mg daily for adults in 2-4 divided doses.
Use for children and adolescents (0 up to 18 years)
Dose one for children and adolescents should be adjusted according to body weight and increased gradually. The usual starting dose is about 0.3 mg/kg / day, divided into 2-4 dosing times that are increased gradually at about one week intervals until the optimal effect has been achieved. A usual maintenance dose is between 0.75 and 2 mg/kg body weight.
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 tablets are not suitable for children under 33 kg in body weight.
The tablets should be taken with a meal or with a glass of milk to counteract stomach upset.
The tablet can be divided into two equal parts. It is recommended that you use a tablet divider to halve the tablet.
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 Alternova.
Symptoms of overdose may be fatigue, hallucinations, impaired consciousness and coma ( coma ), seizures, sudden muscle twitching, muscle tone, breathing difficulties, slow, fast or irregular heartbeat, low or elevated blood pressure, low body temperature, reduced pupillary reflexes, muscle breakdown ( rhabdomyolysis ) and renal impairment, transient effects on liver function, nausea, vomiting, diarrhea.
If you forget to take Baclofen Alternova
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Baklofen Alternova
Do not stop treatment without talking to your doctor first. The treatment should be stopped gradually over 1-2 weeks to avoid the muscle cramps temporarily increasing. A sudden interruption can, especially after long-term treatment, also cause e.g. hallucinations, anxiety and confusion states, and palpitations.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A very common side effect is (can occur in more than 1 in 10) :
- Drowsiness
Common side effects are (may affect up to 1 in 10):
- Fatigue
- Headache
- Dizziness
- Low blood pressure
- Nausea, vomiting
- Constipation
- Diarrhea
- Impaired respiratory function
- Confusion
- Difficulty sleeping
Less common side effects are (may affect up to 1 in 100):
- Sweating
- Weight gain
- Ankle edema (swelling due to fluid retention)
- Rash
- Itching
- Muscle weakness
- Nightmares
- Frequent urination
- Sexual dysfunction
Rare side effects are (may affect up to 1 in 1000 people):
- Muscle pain
- Palpitation
- Chest pain
- Fainting attack
- Epileptic seizures
- Ant crawls
- Difficulty coordinating muscle movements
- Coordination difficulties
- Tremors
- Stiffness
- Abnormally increased muscle tension
- Slurred speech
- Increased spasticity
- Taste
- Exhilaration
- Excitement
- Depression
- Hallucinations (especially in the elderly)
- Difficulty throwing water
- Involuntary urination
- Blurred vision, trembling involuntary movements of the eyelids
- Squint
- Pupil reduction
- Dry mouth
- Elevated blood glucose levels
- Elevation of certain liver values in the blood
Very rare side effects are (may affect up to 1 in 10 000 users):
- Lowered body temperature
Has been reported (occurs in an unknown number of users):
- Hives
- Slow pulse ( bradycardia )
- Withdrawal syndrome
- Difficulty breathing during sleep (sleep apnea syndrome)
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se
5. How to store Baclofen Alternova
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the can and carton after EXP and on the blister after EXP. The expiration date is the last day of the specified month.
Medicines 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, 1 tablet contains 10 mg and 25 mg baclofen respectively.
- The other ingredients are microcrystalline cellulose, corn starch, povidone, colloidal anhydrous silica, magnesium stearate.
What the medicine looks like and the contents of the pack
Baclofen Alternova 10 mg: Ø 7 mm white, round tablet with a scoreline, marked “10”.
Baclofen Alternova 25 mg: Ø 8 mm white, round tablet with a scoreline.
10 mg tablet:
Jar: 50 and 200 tablets
Blister pack: 98 and 100 tablets
25 mg tablet:
Jar: 50 tablets
Blister pack: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Alternova A / S
Lodshusvej 11
4230 Skælskør
Denmark
Manufacturer:
EDMOND PHARMA Srl
Strada Statale dei Giovi 131
20037 Paderno Dugnano – Milan
Italy
or
Viminco A / S
Lodshusvej 11
4230 Skælskør
Denmark