200 mg / ml injection solution 
phenobarbital

1. What Fenemal Meda is and what it is used for

Fenemal Meda contains phenobarbital which counteracts seizures and shortens seizures that occur by limiting the spread of irritation in the brain.

Fenemal Meda is used for epilepsy, in so-called generalized tonic-clonic epileptic seizures ( grand mal ), and for seizures where only parts of the brain are affected ( partial seizures ). Fenemal Meda is an alternative medicine to diazepam for status epilepticus .

Fenemal Meda is used for seizures during the neonatal period.

2. What you need to know before using Fenemal Meda

Do not use Fenemal Meda

  • if you have a disease that involves the formation of porphyrins in the liver ( acute intermittent porphyria )
  • if you are hypersensitive to certain sedatives and sleeping pills ( barbiturates )
  • if you have severe liver damage
  • if you are allergic to phenobarbital or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Fenemal Meda.

Skin reactions, which may be life-threatening ( Stevens-Johnson syndrome and toxic epidermal necrolysis ), have been reported with the use of phenobarbital. It can start as red-violet target-like or round spots with blistering in the middle, often symmetrically spread, on the torso.

Additional signs to be aware of are sores in the mouth, throat, nose, genitals, or eye inflammation (red and swollen eyes).

The skin reactions, which can be life-threatening, are often followed by flu-like symptoms. The rash can develop into blisters over large areas of skin detachment.

The risk of serious skin reactions is greatest during the first weeks of treatment.

If you have had Stevens-Johnson syndrome or toxic epidermal necrolysis while using phenobarbital contained in Fenemal Meda, you should never use medicines containing phenobarbital again.

If you get a rash or signs of these skin reactions, stop taking Fenemal Meda immediately, and contact your doctor immediately and tell them that you are taking this medicine.

If you have impaired liver or kidney function, you should consult a doctor before starting treatment with Fenemal Meda.

To avoid tooth damage due to dry mouth, it is important to brush your teeth with fluoride toothpaste twice daily.

If a rash occurs, the treating physician should be consulted.

If you stop taking Fenemal Meda too quickly, there is a risk of an increased number, and possibly more severe, seizures. If the medical treatment is to be terminated, it is therefore very important that the phasing out takes place slowly, often over the course of 3-12 months. However, never change your treatment yourself without consulting a doctor.

If you get a rash, fever, joint pain, jaundice (whites of the eyes and skin turn yellow), enlarged lymph nodes, you should contact a doctor as soon as possible. This may be a sign of hypersensitivity syndrome.

A small number of people who are treated with antiepileptic drugs such as phenobarbital have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.

Other medicines and Fenemal Meda

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines containing so-called beta-blocker blockers are often used to treat high blood pressure, angina, and migraine prevention, medicines used after myocardial infarction or unstable angina (ticagrelor), medicines for epilepsy (midazolam), birth control pills, certain strong painkillers, so-called opioids, and also some other drugs. may affect or be affected by treatment with Fenemal Meda. The treating physician, therefore, needs to know about other concomitant medications.

Herbal remedies containing St. John’s wort ( Hypericum perforatum ) should not be used during medication with Fenemal Meda. If you are already taking a St. John’s wort preparation, consult a doctor before stopping this preparation.

Pregnancy, breastfeeding, and fertility

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.

There is a risk of fetal harm effects. Do not use phenobarbitone Meda during pregnancy except on certain prescriptions from the doctor. A breastfed baby may be affected. Therefore, do not use Fenemal Meda while breast-feeding, as otherwise prescribed by a doctor.

Driving and using machines

During treatment with Fenemal Meda, the ability to react may be reduced. This should be taken into account when sharper attention is required, e.g. while driving.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Fenemal Meda contains propylene glycol, ethanol, and sodium

This medicine contains 400 mg of propylene glycol per ml.

If your child is younger than 4 weeks, consult a doctor or pharmacist before using the medicine, especially if the child is taking other medicines that contain propylene glycol or alcohol.

This medicine contains 140 mg of alcohol ( ethanol ) per ml. The amount in ml of this medicine corresponds to less than 4 ml of beer or 2 ml of wine.

The low amount of alcohol in this medicine does not produce any noticeable effects.

This medicine contains 14.4 mg sodium (the main ingredient in table salt/table salt) per ml. This corresponds to 0.72% of the highest recommended daily intake of sodium for adults.

3. How to use Fenemal Meda

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

Dose one is determined by the doctor, who adjusts it individually for you.

Dosage one of Fenemal Meda varies greatly from person to person.

The doctor adjusts the size of the dose concerning the level of Fenemal Meda in the blood, how the medicine affects the disease, and how you as a patient feel.

If you take more Fenemal Meda then you should

If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

4. Possible side effects

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

Common ( may affect up to 1 in 10 people ): Drowsiness, which may be postpartum, and difficulty concentrating. Rash. Inability to coordinate muscle movements and involuntary eye movements. Excessive irritability in children and confusion in the elderly.

Uncommon (may affect up to 1 in 100 people): Dry mouth, calcification of the skeleton after prolonged treatment.

Rare ( may affect up to 1 in 1,000 people ): A special form of anemia (megaloblastic anemia ). Skin and mucous membrane changes (sometimes severe). Severe widespread skin damage (skin detachment).

Very rare ( may occur in up to in 10 000 users ): Skin reactions, which can be life-threatening ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) have been reported (see section 2).

Hypersensitivity symptoms may occur, usually, within the first 2 months of treatment, see “What to think about before and when using Fenemal Meda”.

There have been reports of bone diseases e.g. decreased bone density in the skeleton, osteoporosis, and bone fractures. Contact a doctor or pharmacist if you are being treated with epilepsy medication for a long time, if you know you have osteoporosis or if you are on medication with steroids.

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 the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Fenemal Meda

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (2 ° C – 8 ° C), in the original package.

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 phenobarbital 200 mg per milliliter.
  • The other ingredients are Propylene glycol, ethanol, sodium hydroxide to pH8.5–9.5, and water for injections.

What the medicine looks like and the contents of the pack

The unstained solution in 1 ml glass ampoule.

Packaging: 10 x 1 ml.

Marketing Authorisation Holder

Meda AB, Box 906, 170 09 Solna.

Muhammad Nadeem

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