300 mg soft capsules
clomethiazole disilate

Read all of this leaflet carefully before you 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 or pharmacist.
  • 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 or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet:
1. What Heminevrin is and what it is used for
2. What you need to know before taking Heminevrin
3. How to take Heminevrin
4. Possible side effects
5. How to store Heminevrin
6. Contents of the packaging and other information

1. What Heminevrin is and what it is used for

Heminevrin has sedative, sleep-inducing, and antispasmodic effects due to the inhibitory effect of the drug on some of the brain’s functions.

Heminevrin capsules are used for:

  • confusion, anxiety and difficulty sleeping in geriatric care
  • treatment of various symptoms after alcohol abuse

Clomethiazole disilate contained in Heminevrin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before taking Heminevrin

Do not take Heminevrin:

  • if you are allergic to clomethiazole disilate or any of the other ingredients of this medicine (listed in section 6).
  • if you have poor lung function

Warnings and cautions

Talk to your doctor or pharmacist before taking Heminevrin.

If you have sleep apnea syndrome, impaired lung function, liver damage, or impaired kidney function, consult a physician before starting treatment with Heminevrin. The same applies to people who are at risk of brain or heart complications during the treatment (due to the risk of low blood pressure and palpitations), this is especially true of elderly patients.

Heminevrin can be addictive and there is a risk that the body will get used to Heminevrin during prolonged use and that the effect will thus diminish. A period of poor sleep can occur when you stop taking Heminevrin and therefore Heminevrin should only be used for a short time.

Concomitant use of Heminevrin and alcohol should be avoided (risk of inhibition of brain function). The same risk exists with the concomitant use of other drugs with inhibitory effects on some of the brain’s functions.

Children and young people

Children and adolescents under 18 years of age should not take Heminevrin soft capsules.

Other medicines and Heminevrin

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

Heminevrin may affect or be affected by certain medicines containing the following active substances:

  • Cimetidine (medicine for stomach ulcers )
  • Chlorzoxazone (muscle relaxant)
  • Carbamazepine (drugs against epilepsy )
  • Propranolol (medicine for high blood pressure )

Heminevrin with alcohol

Concomitant use of Heminevrin and alcohol should be avoided (see “Warnings and Precautions”).

Pregnancy and breastfeeding

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

Pregnancy: Clometiazole should not be used during pregnancy unless there are strong reasons for use. Talk to your doctor before using Heminevrin during pregnancy.

Breast-feeding: Clomethiazole is excreted in human milk but is unlikely to affect the breast-fed baby. However, consult a physician before using Heminevrin during breastfeeding.

Driving and using machines

When treating with Heminevrin capsules, avoid driving and using machines. This is because the medicine may reduce your ability to react. When Heminevrin capsules are used as a sleeping pill, day-after-day effects may occur even if they are uncommon. The risk increases when consuming alcohol.

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.

Heminevrin contains sorbitol

One Heminevrin capsule contains 7 mg sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Heminevrin

Always take this medicine exactly as your doctor has told you. Always follow your doctor’s prescription and the instructions on the pharmacy label. Dose one is determined by the doctor who adjusts it individually for you.

The soft capsules should be swallowed whole with a sufficient amount of water. Other modes of administration, such as rectal administration or chewing or dividing the capsules, are not recommended.

Ask your doctor or pharmacist if you are unsure.

If you take more Heminevrin than you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to take Heminevrin

Take the missed dose as soon as you remember. If it is soon time for your next dose, skip the missed dose. Do not take a double dose (two doses at the same time) to compensate for a missed dose .

If you stop taking Heminevrin

A period of poor sleep can occur when you stop taking Heminevrin.

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.

Stop taking Heminevrin and contact a doctor immediately if you get any of the following symptoms:

Sudden wheezing, swelling of the lips, tongue and throat or body, rash, fainting or difficulty swallowing ( allergic reaction ).

This is a rare side effect and affects less than 1 in 1,000 people.

Common (affects more than 1 user in 100): Irritation of the nose and eyes (may decrease or disappear with continued treatment).

Uncommon (affects less than 1 user in 100):

  • Gastrointestinal disorders (acid regurgitation, stomach pain, nausea, diarrhea, vomiting)
  • Itching
  • Hives
  • Runny nose and nasal congestion
  • Increased mucus production in the throat and trachea
  • Elevated liver enzyme levels (goes back when you stop taking the medicine)
  • Headache

Rare (affects less than 1 user in 1,000):

  • Allergic reaction
  • Bladder-like rash
  • Low blood pressure
  • Liver effects including jaundice

No known frequency (cannot be calculated from the available data):

  • Stinging sensations (ant crawls)
  • Severe hypersensitivity reaction (anaphylactic shock )
  • Impaired respiratory function
  • Cardiac arrest
  • Facial edema

Reporting of side effects

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. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Heminevrin

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 carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

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 clomethiazole 192 mg equivalent to clomethiazole disilate 300 mg.
  • The other ingredients are medium chain triglycerides , gelatin, glycerol 85%, mannitol, sorbitol (sweetener), hydrogenated partially hydrolysed starch , titanium dioxide (dye E 171), brown iron oxide (dye E 172).

What the medicine looks like and contents of the pack

Heminevrin capsules are soft and gray-brown. They are provided in glass jars with 25 or 3 x 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Manufacturer

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 23-24

17489 Greifswald

Germany

For further information on this medicine, please contact:

Propharma Group AB

Fleminggatan 18

Tel. 08-21 54 45

Fax. 08- 21 54 46

Email: pharmacovigilance.SE@propharmagroup.com

Muhammad Nadeem

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