Hermolepsin Retard 100 mg, 200 mg, 300 mg prolonged-release tablets are

carbamazepin

What Hermolepsin Retard is and what it is used for

Hermolepsin Retard belongs to a group of medicines called antiepileptics. It works by preventing the spread of the signals in the brain that trigger an epileptic seizure. In epilepsy and alcohol withdrawal reduces the risk of seizures and withdrawal symptoms are alleviated.

Hermolepsin Retard is used in the treatment of epilepsy and certain forms of facial pain ( trigeminal neuralgia ) and alcohol withdrawal.

Carbamazepine contained in Hermolepsin Retard may also be approved for the treatment of other conditions not mentioned in this product information. 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 you use Hermolepsin Retard

Do not take Hermolepsin Retard

  • if you are allergic to carbamazepine, any of the other ingredients of this medicine (listed in section 6) or closely related medicines (eg some medicines for depression called tricyclic antidepressants )
  • if you suffer from porphyria (disorder in the formation of porphyrin, ie a pigment that is important for
  • liver function and for hematopoiesis)
  • if you have a certain type of heart disease ( AV block )
  • if you have previously had a certain type of blood disease (bone marrow suppression).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Hermolepsin Retard:

  • if you are taking antidepressants or medicines used to treat Parkinson’s disease from the group of monoamine oxidase inhibitors ( MAOIs ). Treatment with MAOIs must be stopped at least 14 days before you can start treatment with Hermolepsin Retard .
  • if you have cardiovascular disease. 
  • if you have liver or kidney disease including inability to empty your bladder.
  • if you have previously shown signs of hypersensitivity (rash or other signs of allergy ) to the substance oxcarbazepine, phenobarbital or phenytoin . For people who are hypersensitive to carbamazepine, there is a risk that about one in four patients (25%) will also have an allergic reaction to oxcarbazepine (Trileptal). 
  • If you are a woman and could become pregnant, you should use an effective method of contraception throughout the treatment and for 2 weeks after the last dose . If you are taking hormonal contraceptives, e.g. birth control pills Hermolepsin Retard can cause your contraceptive to not work. Use another or a supplemental (non-hormonal) method of contraception while taking Hermolepsin Retard to prevent unwanted pregnancy. Contact your doctor immediately if you experience irregular bleeding or breakthrough bleeding. Ask your doctor or other healthcare professional if you have any questions about this. 
  • Contact your doctor if you become pregnant or are planning to become pregnant. Your doctor will tell you about the possible risks of taking Hermolepsin Retard during pregnancy as there is a risk of birth defects (see section Pregnancy, breast-feeding and fertility ). 
  • if you have kidney problems associated with low sodium levels in your blood, or if you have kidney problems while taking certain medicines that lower your blood sodium levels ( diuretics , such as hydrochlorothiazide , furosemide ). You may need to take blood samples to check your sodium levels. 
  • Hermolepsin Retard is given with caution to the elderly and to patients with elevated eye pressure or previous bone marrow disease .
  • if you experience dizziness, drowsiness, decreased blood pressure , confusion due to treatment with Hermolepsin Retard which may cause you to fall.

If symptoms of blood, liver, or skin changes occur, contact your doctor immediately. Sore throat, fever, bleeding, or allergic skin reactions are examples of such symptoms (see also section “Possible side effects”).

Severe skin rash ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) has been reported with the use of carbamazepine. It can start as red-violet target-like or round spots with blistering in the middle, often symmetrically spread, on the torso. The rash can often include sores in the mouth, throat, nose, genitals, and conjunctivitis (red and swollen eyes). These severe skin rashes, which can be life-threatening, are often preceded by flu-like symptoms such as fever, headache, and body aches. The rash can develop into extensive blistering over large areas and peeling of the skin or skin detachment. The risk of serious skin side effects is greatest during the first months of treatment.

These serious skin side effects may be more common in people from certain Asian countries (eg Taiwan, Malaysia, and the Philippines) as well as in patients of Chinese or Thai descent. The risk of these side effects in patients of Han Chinese or Thai origin can be determined by a blood test in these patients. Doctors should be able to tell you if a blood test is necessary before you start taking carbamazepine. Therefore, consult your doctor before starting treatment with Hermolepsin Retard if you are of Chinese or Thai descent.

If you develop a rash or these skin symptoms described here, you should stop taking carbamazepine-containing medicines and contact a doctor immediately and tell them that you are taking this medicine. If you have had Stevens-Johnson syndrome or toxic epidermal necrolysis while using carbamazepine contained in Hermolepsin Retard, you should never use carbamazepine-containing medicines again.

A small number of people who are treated with antiepileptic drugs such as carbamazepine have also been thought to harm themselves or commit suicide. If you ever get these thoughts, contact your doctor immediately.

Medicines used to treat epilepsy can lead to folic acid deficiency, which is why your doctor may prescribe folic acid preparations during treatment.

As Hermolepsin Retard may cause dry mouth, careful oral hygiene should be observed (brushing with fluoride toothpaste twice daily).

Other medicines and Hermolepsin Retard

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

If you are taking antidepressants or medicines used to treat Parkinson’s disease from the group of monoamine oxidase inhibitors ( MAOIs ), that treatment must have been stopped for at least 14 days before you can start taking Hermolepsin Retard.

The treatment effect of Hermolepsin Retard may be affected if it is taken at the same time as certain other medicines. The treatment effect of other medicines can also be affected if they are taken at the same time as Hermolepsin Retard. Therefore, consult your doctor before using other medicines at the same time. This applies to both prescription and over-the-counter medicines.

This is especially true for the following medicines:

  • certain painkillers (eg dextropropoxyphene )
  • sedatives (eg midazolam)
  • Hormonal contraceptives (such as birth control pills ) may be less effective. Therefore, use another or a complementary (non-hormonal) method of contraception when taking Hermolepsin Retard . For more information, see section 2, Warnings and Precautions.
  • (traditional) herbal medicines containing St. John’s wort ( Hypericum )
  • perforatum) should not be used during medication with Hermolepsin Retard . If you are already taking a St. John’s wort preparation, consult your doctor before stopping this preparation.
  • cardiac drugs (eg ivabradine , digoxin )
  • Cholesterol-lowering drugs (eg simvastatin )
  • against cardiovascular diseases (felodipine, nimodipine, verapamil, diltiazem )
  • in sex hormone therapy ( birth control pills , danazol)
  • in hormone therapy ( corticosteroids are eg prednisolone , dexamethasone)
  • against infection are ( doxycycline , erythromycin, isoniazid , clarithromycin)
  • against pain ( methadone , paracetamol , tramadol)
  • for epilepsy (etosuximide, felbamate, phenobarbital, phenytoin , clobazam, clonazepam, lamotrigine, levetiracetam, eslicarbazepine, oxcarbazepine, primidone, thiagabine, topiramate, valproic acid , vigabatrin, zonisamide)
  • for depression / depression (amitriptyline, citalopram , desipramine, doxepine, imipramine, fluoxetine , fluvoxamine, clomipramine, mianserin, mirtazapine, nefazodone, nortriptyline, sertraline , trazodone, viloxazine)
  • against anxiety (alprazolam)
  • against vomiting and nausea (ondansetron, metoclopramide)
  • which are blood thinners (dicumarol, ticlopidine, warfarin , rivaroxaban, dabigatran, apixaban, edoxaban)
  • some that inhibit the immune system (cyclosporine)
  • which are muscle relaxants (pancuron, rocuronium, vekuroium)
  • against viral diseases (delavirdine, indinavir, ritonavir, sofosbuvir)
  • against parasitic worms (praziquantel)
  • against psychosis are ( haloperidol , clozapine, lithium, risperidone , thioridazine)
  • against fungal infections ( fluconazole , itraconazole, ketoconazole , terbinafine)
  • against asthma or allergies ( loratadine , theophylline, terfenadine, fexofenadine)
  • which are diuretic (acetazolamide, furosemide , hydrochlorothiazide)
  • against stomach ulcers and heartburn (cimetidine)
  • against tuberculosis (rifampicin)
  • against thyroid disease ( thyroxine )
  • containing nicotinamide ( vitamin B )
  • against cancer (erlotinib, irinotecan, lapatinib)
  • mot schizophrenia (aripiprazole, olanzapine, quetiapine, ziprasidone).

Therefore, always tell your doctor that you are taking Hermolepsin Retard for another medicine.

Hermolepsin Retard with food, drink and alcohol

You should not drink alcohol in conjunction with Hermolepsin Retard treatment, as Hermolepsin Retard may impair your ability to tolerate alcohol.

You should not drink grapefruit juice during treatment with Hermolepsin Retard as this may enhance the effect of the medicine.

Pregnancy, breastfeeding and fertility

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

Contraceptives in women

If you are a woman and could become pregnant, you should use effective contraception throughout the treatment and for 2 weeks after the last dose. Hermolepsin Retard may reduce the effect of birth control pills and other contraceptives that contain hormones. Discuss the choice of contraceptive with your doctor. See also section Warnings and Precautions.

Pregnancy

When you take Hermolepsin Retard, there is a risk of birth defects. Hermolepsin Retard should therefore not be used during pregnancy unless necessary (unless the benefit to you clearly outweighs the potential risk to the fetus). Your doctor will tell you about the benefits of the treatment and any risks and help you decide whether to take Hermolepsin Retard.

It is important that epileptic seizures are kept under control during pregnancy. Do not stop taking Hermolepsin Retard during pregnancy without first talking to your doctor.

Breast-feeding

Carbamazepine passes into breast milk. Talk to your doctor or pharmacist before taking Hermolepsin Retard regarding the risk of side effects in your baby while breastfeeding.

Driving and using machines

Hermolepsin Retard can make you feel sleepy or dizzy. You may also have blurred vision, double vision, or difficulty coordinating muscle movements, especially at the beginning of your treatment or after a dose increase. This should therefore be taken into account when sharper attention is required, e.g. when driving a car or other vehicle, using machines, or performing other activities that require increased vigilance.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform risky work. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Hermolepsin Retard contains excipients

Hermolepsin Retard contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other excipients

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

3. How to use Hermolepsin Retard

Always take this medicine exactly as your doctor 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. Carefully follow your doctor’s prescription.

This is especially important in epilepsy in order for you to get adequate anticonvulsant protection. Initially, a lower dose is given which is then gradually increased until the effective maintenance dose is reached.

The daily dose can vary greatly depending on age, body weight, and the severity of the seizures. Blood tests at the beginning and during treatment can therefore be helpful. Dose one should be inserted in a slowly increasing dose. As a rule, Hermolepsin Retard is dosed up to freedom from seizures or until side effects begin to occur.

The usual dose for adults with epilepsy: at the beginning of treatment 100 mg twice daily with meals. Dose one is usually increased by 200 mg per week until the effective maintenance dose is reached. This is usually 400-600 mg twice daily.

The usual dose for children with epilepsy: 10–20 mg/kg body weight per day, divided into several doses, which are used in slowly increasing doses.

The usual dose for trigeminal neuralgia (certain forms of facial pain): 600-800 mg daily in 2 divided doses. The maximum recommended dose is 1200 mg per day.

The usual dose for alcohol withdrawal: 600-800 mg daily.

How to take Hermolepsin Retard

Tablets should be taken during or after a meal and with liquid.

The prolonged-release tablet is divisible but must not be crushed or chewed.

If you use more Hermolepsin Retard than you should 

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

If you forget to use Hermolepsin Retard

If you forget to take a dose , take it as soon as you remember. However, if it is time for the next dose , do not take the one you forgot. Continue with your usual dosing schedule. Do not take a double dose to make up for a forgotten dose .

If you stop using Hermolepsin Retard

When treating epilepsy , you should not abruptly stop your medication as the risk of seizures then increases. Never change your treatment yourself without consulting a doctor.

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

4. Possible side effects

Like all medicines, Hermolepsin Retard can cause side effects, although not everybody gets them.

Some side effects can be serious. Seek medical attention immediately if you get any of the following:

Agranulocytosis (rare side effect ) :

Hermolepsin Retard can in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe deteriorating general condition or fever with local infection symptoms such as sore throat / throat / mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytos ). It is important that you then inform about your medication.

Angioedema (very rare side effect ) :

Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing.

Toxic epidermal necrolysis (very rare side effect ):

Severe widespread skin damage (skin detachment of the epidermis and superficial mucous membranes), see section 2.

Stevens-Johnson syndrome (very rare side effect ):

An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals, see section 2.

Liver disease (rare side effect ):

For example. jaundice (yellowing of the skin or whites of the eyes).

Decreased platelet or blood cell count (common side effect ):

Shows signs such as fatigue, shortness of breath on light exertion, paleness, headache, chills, dizziness, recurrent infection with fever, sore throat, cold sores, bleeding or bruising that occurs more easily than normal, nosebleeds, reddish or red-violet marks on the skin or unexplained blemishes .

SLE -like disease (rare side effect ):

Causes red, spotty skin rashes, mainly on the face, which may occur at the same time as fatigue, fever, nausea or loss of appetite.

Porphyria (rare side effect ):

Leads to increased excretion of blood dyes in the urine which is darkened.

Effects on renal function (rare side effect ):

Severe decrease in the amount of urine, or blood in the urine.

Pancreatitis (very rare side effect ):

Severe upper abdominal pain, vomiting, loss of appetite.

Low levels of sodium in the blood (rare side effect ):

Shows signs such as lethargy, confusion, muscle twitching or significant worsening of seizures (these symptoms may be signs of a low level of sodium in the blood).

Meningitis (rare side effect ):

Shows signs such as fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light.

Neuroleptic malignant syndrome (very rare side effect ):

Gives a sudden increase in body temperature, very high blood pressure and severe cramps.

Cardiac effects (rare side effect ):

For example. irregular heartbeat, chest pain.

Inflammation of the colon (has been reported):

Shows signs such as diarrhea, abdominal pain and fever.

Cases (reported) :

If you fall due to dizziness, drowsiness, decreased blood pressure , confusion.

The following side effects may also occur with the use of Hermolepsin Retard:

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

  • Difficulty coordinating muscle movements, dizziness
  • Vomiting, nausea
  • Fatigue
  • Elevated liver function values

Common (may affect up to 1 in 10 people)

  • Increase of blood s
  • Fluid retention , decreased appetite
  • Double vision, difficulty seeing up close
  • Dry mouth
  • Hives, rash
  • Elevation of certain enzymes (alkaline phosphatases) in the blood

Uncommon (may affect up to 1 in 100 people)

  • Headache, involuntary movements (eg tremors, twitching), eye tremors ( nystagmus ), painful facial movements
  • Diarrhea, constipation

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

  • Delayed hypersensitivity reaction
  • Breast augmentation in men, milk flow from the breasts even without breastfeeding
  • Folate deficiency
  • Hallucinations, depression, aggression, anxiety, restlessness, confusion and activation of psychotic symptoms
  • Disorder of eye movements, speech disorders, nerve inflammation in arms and legs, ant crawling, muscle weakness
  • Clouding of the lens of the eye, inflammation of the eyes
  • Tinnitus, increased sensitivity to sound
  • Elevation or decrease in blood pressure , inflammation of a blood vessel that hurts ( thrombophlebitis )
  • Allergic lung problems that may resemble pneumonia ,
  • Abdominal pain, taste disturbances, inflammation of the tongue or oral mucosa
  • Allergic skin reactions, hypersensitivity reaction to sunlight, altered skin pigmentation, slight bleeding in the skin, itching , acne , sweating, hair loss, increased hair (including women)
  • Decalcification of bone tissue and osteoporosis after long-term treatment, joint pain, muscle aches, muscle cramps
  • Difficulty or increased need to throw water
  • Sexual disability
  • Fever, decreased thyroid function

Very rare (may affect up to 1 in 10,000 people)

  • Hearing loss, change of tone perception
  • Increase in breast milk stimulating hormone ( prolactin ) in the blood

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

  • Anemia , decreased number of antibodies (gamma globulin) in the blood
  • Male infertility
  • Increased pressure in the eye
  • Reactivation of infection with human herpesvirus 6, bone marrow failure
  • Sedation , memory impairment
  • Hypersensitivity syndrome involving allergic reaction with rash, fever and abnormal blood counts (DRESS)
  • AGEP ( acute generalized exanthematous pustulosis ) which may present with a sudden onset of fever with large redness , small strongly red-spotted rash, with very small blisters
  • Thickening of the skin, loss of nails, fracture

There have been reports of bone diseases e.g. reduced 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 any side effects 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

www.lakemedelsverket.se

5. How to store Hermolepsin Retard

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

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton. 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 carbamazepine 100 mg, 200 mg and 300 mg respectively
  • The other ingredients are: lactose monohydrate 15 mg, 30 mg and 45 mg respectively,
    corn starch, microcrystalline cellulose, castor oil, gelatinized starch , polysorbate 80, povidone, sodium starch glycollate, magnesium stearate.

What the medicine looks like and contents of the pack

The prolonged-release tablets of 100 mg and 200 mg are white, round, cupped with a notch. diameter 9 mm and 11 mm, respectively.
The prolonged-release tablets of 300 mg are white, round, flat with a notch, diameter 13 mm.

Hermolepsin Retard prolonged-release tablets: plastic jar, 100 prolonged-release tablets .

Marketing Authorisation Holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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