10 mg / 50 mg / 10 mg tablet
Prometazine Hydrochloride / Caffeine / Ephedrine sulphate
What Lergigan Comp Is And What It Is Used For
Lergigan Comp English contains promethazine, caffeine, and ephedrine and belongs to the group of antihistamines. Promethazine blocks the effect of histamine, a substance found in the body’s tissues that, among other things, triggers itching in allergic reactions. Promethazine means that Lergigan comp also has a calming effect. Ephedrine and caffeine enhance the effects of motion sickness and pregnancy nausea.
Lergigan comp is used against:
- Tension and anxiety in nervous disorders.
- Alcohol abuse and drug addiction.
- Sleep disorders.
- Severe anxiety and as a sedative before surgery and dental procedures.
- Motion sickness, such as seasickness.
- Skin itching and allergies.
- Nausea and dizziness
What You Need To Know Before Using Lergigan Comp
Do Not Use Lergigan Comp
- If you are allergic to prometazine, caffeine, ephedrine sulphate, or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Talk to your doctor or pharmacist before using Lergigan comp as lergigan side effects vary person to person :
- If you suffer from an enlarged prostate.
- If you suffer from narrowing of the urethra.
- If you suffer from narrowing of the lower gastrointestinal tract and duodenum (pyloroduodenal obstruction ).
- If you have jaundice ( hepatitis ).
- If you have myasthenia gravis (severe muscle weakness).
- If you suffer from cardiovascular disease or changes in heart rhythm.
- If you have a risk of cerebral haemorrhage ( stroke ).
- If you have high blood pressure.
- Due to dry mouth (which is a common side effect), there is a risk of tooth and oral mucosal damage, especially with prolonged use. You should therefore brush your teeth thoroughly with fluoride toothpaste twice daily.
Treatment with Lergigan Comp English can cause problems for contact lens wearers due to reduced tear flow.
Other Drugs And Lergigan Comp
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.
Lergigan Comp English may affect or be affected if taken at the same time as certain other medicinal substances against:
- Cardiac drugs are given directly into the bloodstream (eg adenosine ).
- Infection (eg ciprofloxacin , norfloxacin).
- Depression ( tricyclic antidepressants ).
- Allergic nasal congestion (eg phenylpropanolamine).
- Epilepsy (eg carbamazepine).
- Certain psychiatric conditions (eg lithium and neuroleptics such as haloperidol, clozapine, and risperidone ).
- Anxiety (eg diazepam).
- High blood pressure (eg beta-blockers and alpha-blockers).
- Arrhythmias in the heart (eg flecainide and amiodarone).
- Certain antibiotics (moxifloxacin and erythromycin).
- Pain conditions (eg methadone).
- Malaria drug (meflokin).
- Intestinal disease (eg cisapride).
Avoid concomitant treatment with certain diuretics (thiazide diuretics), as these may reduce the level of potassium in the blood and thus increase the risk of arrhythmias in the heart.
Lergigan Comp With Food, Drink, And Alcohol
Concomitant use of alcohol or central suppressants should be avoided due to the risk of enhanced drug effects.
Lergigan Comp 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 or pharmacist for advice before taking this medicine.
Lergigan Comp pregnancy effects.
Promethazine and ephedrine
No known hazards during use.
Caffeine
Pregnant women are advised to limit their caffeine intake as available data suggest a possible risk to the fetus.
Breast-feeding
Caffeine passes into breast milk but probably does not affect breastfed babies. No information is available on promethazine and ephedrine passing into breast milk. Therefore, consult a physician before regular use during breastfeeding.
Driving And Using Machines:
Lergigan comp side effects during treatment:
During treatment with Lergigan comp, the ability to react may be reduced. 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 Lergigan comp side effects and 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.
Lergigan Comp Contains Sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How To Use Lergigan Comp
- 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 physician, who adjusts it individually for each patient. The usual dose is: 1 tablet 1-2 times daily.
- Nausea and vomiting can be avoided if the tablets are taken with a meal.
Possible Lergigan Side Effects
Lergigan side effects
Like all medicines, Lergigan comp can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
- Dry mouth
Uncommon (may affect up to 1 in 100 people):
- Dizziness
- Headache
- Difficulty
- Throwing water
- Constipation
- Difficulties for the eye to switch between near and far vision
- Reduced tear flow
- Nausea
- Vomiting
- Sweating
- Thirst
- Palpitations
- Muscle weakness
- Tremors
- Anxiety
- Ringing in the ears
- Flicker of the eyes may occur at high doses
Rare (may affect up to 1 in 1,000 people):
- Jaundice without signs of liver damage
- Effects on heart rhythm
- Irregular heartbeat
- ECG changes associated with it
- Cardiac arrest
How To Store Lergigan Comp
- Keep this medicine out of sight and reach of children.
- 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.
- 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.
Contents Of The Pack And Other Information
Content Declaration
The active substances are:
- Promethazine hydrochloride 10 mg.
- Caffeine 50 mg and ephedrine 10 mg.
The other ingredients are:
- Titanium dioxide (E171)
- Glycerol
- Vanilla aroma
- Magnesium stearate
- Anhydrous colloidal silica
- Calcium hydrogen phosphate dihydrate
- Microcrystalline cellulose
- Ethylcellulose
- Hydroxypropylcellulose
- Macrogol
- Sodium starch glycolate
- Sorbitanoleate.
What the Medicine Looks Like And Contents Of The Pack
- Lergigan comp film-coated tablets are 9 mm in diameter, white and round, and cupped with embossing LC within arches.
- Plastic jar with child-resistant lid: 30 tablets.
Marketing Authorisation Holder:
Meda AB
Box 906
170 09 Solna
Phone: 08-630 19 00
Email: info@meda.se