NALGESIN 275mg x 20 film tabl
Leaflet: user information
Nalgesin Ò 275 mg film-coated tablets
Naproxen sodium
Nalgesin Ò 275 mg film-coated tablets
N aproxen sodium
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
- If after 3 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What Nalgesine is and what it is used for
2. What you need to know before you take Nalgesine
3. How to take Nalgesine
4. Possible side effects
5. How to store Nalgesine
6. Contents of the package and additional information
- What Nalgesine is and what it is used for
Nalgesine relieves pain and inflammation and lowers elevated body temperature.
It works by suppressing the synthesis of prostaglandins. The tablets are quickly soluble, which is why a quick pain-relieving effect is obtained.
It is used for short-term symptomatic treatment of pain.
Nalgesine relieves:
- headache and toothache,
- muscle, joint and spine pain,
- migraine,
- menstrual pains,
- muscle and joint pain due to flu and cold.
In infectious diseases, it lowers elevated body temperature and relieves the inflammatory process.
- What you need to know before you take Nalgesine
Inform your doctor if you suffer from a chronic or metabolic disease, if you are hypersensitive or take other medicines.
Do not take Nalgesine
- if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine, to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs,
- if you have an ulcer or other disease of the gastrointestinal tract,
- if you have ever had stomach bleeding,
- if you are simultaneously taking other pain relievers (acetylsalicylic acid or non-steroidal anti-inflammatory drugs),
- more than 10 days for pain relief,
- more than 3 days with fever
You should not give Nalgesine to children under 12 years of age unless directed by a doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nalgesine.
- when the painful area is red or swollen;
- if you regularly take other medicines;
- if you are under medical supervision because you suffer from some chronic diseases;
- if you have had serious side effects after taking some other pain relief medicines.
You should stop taking Nalgesine and consult a doctor:
- if new or unexpected symptoms occur;
- if symptoms persist or even worsen;
- if you have difficulty swallowing;
- if heartburn or stomach pain occurs.
Medicines such as Nalgesine may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose and duration of treatment (3 days to reduce elevated body temperature or 10 days to relieve pain).
If you have heart problems, have had a stroke or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes or high cholesterol or are a smoker), you should discuss your treatment with your doctor or pharmacist.
If you drink alcoholic beverages regularly (three or more glasses a day), discuss the use of Nalgesine with a doctor. In combination with alcohol, Nalgesine can increase the risk of stomach bleeding.
If you have already taken other medicines to relieve pain or reduce a high body temperature and you get hives, facial swelling, an asthma attack or even shock, do not take Nalgesin without consulting a doctor
Nalgesin contains sodium
This medicine contains 25.08 mg of sodium (main ingredient of table/table salt) in each film-coated tablet. This amount is equivalent to 1.25% of the recommended maximum daily dietary intake of sodium for an adult.
Other medicines and Nalgesine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Interactions with other medications may increase or decrease the effects of Nalgesin or other medications. This happens with:
- other painkillers (acetylsalicylic acid or other non-steroidal anti-inflammatory drugs),
- medicines that contain the same active substance, naproxen,
- medicines that prevent blood clotting (anticoagulants) or medicines that dissolve existing blood clots (fibrinolytics),
- medicines to prevent blood clots (Aspirin/acetylsalicylic acid)
- medicines for the treatment of diabetes (sulfanylureas),
- medicines for the treatment of epilepsy (hydantoin derivatives),
- medicines to treat high blood pressure,
- medicines that increase the excretion of urine (furosemide),
- medicines to treat mental illness (lithium),
- immunosuppressants (cyclosporine),
- medicines for the treatment of malignant diseases (methotrexate).
Nalgesine with food and drink
Take the tablets whole with liquid. You can take them before, during or after a meal.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Preclinical studies in animals have shown no adverse effects on pregnancy and fetal development.
Naproxen is not recommended during pregnancy. The doctor will assess whether the potential benefit to the pregnant woman outweighs the risk to the fetus. Therefore, during pregnancy, you should take medicines only after consulting a doctor.
You should not take the medicine during the last trimester of pregnancy.
Breastfeeding is not recommended during treatment with Nalgesine.
Driving and using machines
Naproxen is not known to have a significant influence on the ability to drive and use machines.
Nalgesin contains sodium
Each Nalgesine tablet contains about 25 mg of sodium. Keep this in mind if you're on a salt-restricted diet.
- How to take Nalgesine
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose is 1 tablet every 12 hours (up to a maximum of 2 tablets daily) for as long as symptoms persist, but not longer than indicated in point 2.
Initially, you can take a double dose: two tablets at the same time or the second tablet after an hour interval.
If you have the impression that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
Old age
If you are older than 65 years, take 1 tablet every 12 hours as needed, unless your doctor has advised you otherwise.
Adverse drug reactions can be reduced by using the lowest possible effective dose for the shortest possible period of time to control symptoms.
If you take more than the required dose of Nalgesin
If you have taken more Nalgesine than you should, consult your doctor or pharmacist immediately .
Excessively high doses of those already prescribed can cause stomach pain, nausea, vomiting, dizziness, tinnitus, irritability, in more severe cases even vomiting of blood (hematemesis), blood in the feces (melena), sensory disturbances, respiratory disorders, convulsions and renal failure.
In case of intentional ingestion of a large number of tablets, the doctor will take appropriate measures.
If you forget to take Nalgesine
Do not take a double dose to make up for a missed dose.
Take Nalgesine only if needed. Never double doses.
If you have stopped taking Nalgesine
If you are taking it for short-term pain relief, you can stop taking it as soon as you no longer need it.
If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
- Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Abdominal pain, vomiting, nausea, dizziness, lightheadedness, fatigue, sleep disturbances, ringing in the ears or swelling of the legs may occur. These are all mild side effects, but if you notice them, please tell your doctor.
Gastrointestinal bleeding, facial oedema, urticaria, asthma attack or loss of consciousness may occur extremely rarely. These are serious side effects that require immediate medical attention.
Medicines such as Nalgesine may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke.
If you notice an adverse reaction, inform your doctor or pharmacist.
Reporting of suspected adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Medicines Executive Agency, 8 Damyan Gruev Street
1303 Sofia
Phone: +35 928903417
website: www.bda.bg.
By reporting adverse reactions, you can contribute to getting more information about the safety of this medicine.
- How to store Nalgesine
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiration date corresponds to the last day of the specified month.
To be stored below 25°C.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
- Package contents and additional information
What Nalgesin contains
- the active substance is: naproxen sodium (naproxen sodium). Each film-coated tablet contains 275 mg of naproxen sodium.
- the other ingredients are: povidone, microcrystalline cellulose, talc, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide (E 171), macrogol, indigo (E 132).
See section 2 "Nalgesine contains sodium".
What Nalgesine looks like and contents of the pack
Film-coated tablets are oval, slightly biconvex and covered with a blue film.
The tablets are available in cardboard boxes with 10 or 20 film-coated tablets in a blister pack. Each box contains 1 blister or 2 blisters of 10 film-coated tablets.
Not all types of packaging can be put on sale.
Marketing Authorization Holder and Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Date of last revision of leaflet
August 2018
