100 mg, 300 mg and 400 mg hard capsules 
gabapentin

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 Delarit is and what it is used for 
2. What you need to know before taking Delarit 
3. How to take Delarit 
4. Possible side effects 
5. How to store Delarit 6. Contents of the pack 
and other ingredients information 

1. What Delarit is and what it is used for

Delirious is used to treat epilepsy in patients with partial-onset epilepsy in addition to other antiepileptic drugs when insufficient efficacy can be obtained with them.

Delirious is also used to treat pain caused by changes in the nerves, for example after shingles infection, as well as in painful nerve disease as a result of diabetes.

Gabapentin contained in Delarit 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 Delarit

Do not take Delarit

  • if you are allergic to gabapentin or any of the other ingredients of this medicine (listed in section 6).
  • if you have acute inflammation of the pancreas.

Warnings and cautions

Talk to your doctor or pharmacist before taking Delarit

  • if you have seizures that include transient unconsciousness.
  • if you have impaired kidney function.
  • if you get symptoms of inflammation of the pancreas (persistent abdominal pain, nausea, repeated vomiting). Contact your doctor immediately.
  • if you have a history of psychotic illness.
  • a small number of people being treated with antiepileptic drugs such as gabapentin have also had thoughts of harming themselves or committing suicide. If you ever get these thoughts, contact your doctor immediately.
  • If you have nervous system disorders, respiratory diseases, or if you are older than 65 years, your doctor may prescribe you a different dosage.

Important information about potentially serious side effect s

A few people who use gabapentin get an allergic reaction or a potentially serious skin reaction that can develop into more serious problems if left untreated. When using gabapentin you should be aware of these symptoms. Read the description of these symptoms in section 4 of this leaflet under “Contact a doctor immediately if, after taking this medicine, you experience any of these symptoms as they may be serious.”

Other medicines and Delarit

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, tell your doctor (or pharmacist) if you are taking or have recently taken medicines for seizures, sleep disorders, depression, anxiety, or any other neurological or mental problems.

If Delarit is taken together with antacids for acid stomach and heartburn (so-called antacids), the effect of gabapentin is reduced. Therefore, take Delarit at the earliest 2 hours after antacids.

Delarit with food, drink,k and alcohol

Delaritis can be taken regardless of the meal.

Consumption of alcohol or illegal drugs can exacerbate any side effects.

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 that gabapentin will harm the fetus, but interruption of epilepsy treatment may also involve risks.

Gabapentin passes into breast milk and the effects on the breast-fed baby can not be ruled out. Therefore, consult your doctor.

Driving and using machines

Gabapentin may cause drowsiness and dizziness, which impairs the ability to react. It can therefore be associated with risks driving and handling machines. This should be especially taken into account when initiating gabapentin therapy and w112hen increasing the dose.

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

Delarite contains lactose

Each Delarit capsule contains 17 mg, 50 mg, and 67 mg of lactose respectively. 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 Delarit

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

The treatment usually starts with a 300 mg capsule in the evening and is then gradually increased to 3 doses per day according to the doctor’s prescription. It should not take more than 12 hours between one evening dose and the next morning dose.

If you are going to reduce the dose one or stop the gabapentin treatment, this should also be done gradually and according to a doctor’s prescription. Excessive termination of treatment can lead to risks of an increased number of epileptic seizures.

Delaritis can be taken regardless of the meal. The capsules should be swallowed whole with at least half a glass of liquid. The capsules should not be chewed.

Delaritis should not be used by children under 12 years of age to treat epilepsy. Delaritis should also not be used by children and adolescents under the age of 18 for the treatment of nerve pain as a result of e.g. shingles infection or diabetes.

If you have the impression that the effect of Delarit is too strong or too weak, talk to your doctor or pharmacist.

If you take more Delarit 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 Delarit

If a single dose has been missed (eg the last dose was taken more than 12 hours ago), contact your doctor, who will assess whether an additional dose is needed.

4. Possible side effects

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

Contact a doctor immediately if, after taking this medicine, you experience any of these symptoms as they may be severe.

Gabapentin can cause a serious or life-threatening allergic reaction that can affect the skin or other parts of the body such as the liver or blood cells . Rash can occur in connection with such a reaction, but it does not always happen. This can lead to you being hospitalized or you may stop taking gabapentin. Contact your doctor immediately if you get any of the following symptoms:

  • rash
  • hives
  • fever
  • swollen glands that do not disappear
  • swollen lips and tongue
  • yellow skin or whites of the eyes
  • unusual bruising or bleeding
  • marked fatigue or weakness
  • unexpected muscle pain
  • frequent infection is
  • breathing problems, where in severe cases you may need emergency and intensive care to continue breathing normally.

These symptoms may be the first signs of a severe reaction. Your doctor should examine you to determine if you should continue to use gabapentin.

Other side effects are:

Common side effects (may affect up to 1 in 10 people):

drowsiness, fatigue, dizziness, headache, insomnia, weight gain, loss of appetite, swelling, weakness, increased appetite, impaired muscle coordination, involuntary eye movements ( nystagmus ), tremors, memory loss, ant crawling, muscle twitching, intensified or weakened reflexes, loss of reflexes, loss of reflexes impaired concentration, thought disorders, speech disorders, impaired memory, abnormal gait, vomiting, nausea, diarrhea, dry mouth , indigestion, constipation, abdominal pain, gingivitis, malaise, nervousness, depression, confusion, mood swings, mood swings, mood swings and mood swings. joint pain, muscle pain, low back pain, bone fractures, low white blood cell count , vasodilation, highblood pressure , nasal congestion, inflammation of the throat, cough, itching , small bleeding in the skin, rash, urine leakage, urinary tract infection, impotence .

Uncommon side effects (may affect up to 1 in 100 people):

accidents, dizziness, confusion, increased sensitivity to touch, flatulence, difficulty swallowing, depression, psychosis / hallucinations, aggression, blood glucose fluctuations, shortness of breath, agitation (a state of constant restlessness and involuntary, meaningless movements).

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

reactions when drug treatment is stopped, such as pain, sweating and chest pain, movement disorders, earring ( tinnitus ), decreased platelet count , changes in blood glucose levels in diabetic patients, palpitations, upper respiratory tract infection, hives , hair loss, acute kidney failure .

Rare cases of swelling of the face and fingers ( angioedema ) have been reported. If you get swelling of the face, feet or ankles, lips, tongue and / or throat and larynx with difficulty swallowing or breathing, discontinue treatment and contact a doctor immediately.

Difficulty breathing, shallow breathing ( respiratory depression ).

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

Anaphylactic reaction (severe allergic reaction that can be life-threatening, with symptoms such as difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure that requires emergency treatment).

Very rare cases of allergic reaction in the form of severe dermatitis and mucositis have been reported.

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Delarit

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

Do not store above 30 ° C.

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.

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 gabapentin 100 mg, 300 mg or 400 mg.
  • The other ingredients are lactose monohydrate , corn starch, talc, gelatin.

Dyes:

100 mg: titanium dioxide (E171).

300 mg: titanium dioxide (E171), iron oxide, yellow (E172).

400 mg: titanium dioxide (E171), iron oxide, yellow and red (E172).

What the medicine looks like and contents of the pack

100 mg: white hard capsules

300 mg: yellow hard capsules

400 mg: orange hard capsules

Marketing Authorization Holder

Rivopharm Ltd.,

17 Corrig Road, Sandyford,

Dublin 18

Ireland

Manufacturer:

Laboratories BTT

ZI de Krafft

67 150 ERSTEIN

France

Holsten Pharma GmbH

Hanstrasse 31-35

Frankfurt am Main

Hessen, 60528

Germany

Agent:

SanoSwiss UAB,

Aukstaiciu str. 26A,

LT-44169 Kaunas,

+370 700 01320

info@sanoswiss.com

Lithuania

Muhammad Nadeem

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