ALKA-SELTZER BRAUSETBL N10

ATC code: N02BA01 

Active substances: Acidum Acetylsalicylicum

Vendor, principal: Bayer Schering Ag. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ALKA-SELTZER 324MG N10

Package leaflet: Information for the user

Alka-Seltzer 324 mg effervescent tablets

Acetylsalicylic acid

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 have any further questions, ask your doctor or pharmacist.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.   What Alka-Seltzer is and what it is used for
2.   What you need to know before you use Alka-Seltzer
3.   How to use Alka-Seltzer
4.   Possible side effects
5.   How to store Alka-Seltzer
6.   Contents of the pack and other information

1. What Alka-Seltzer is and what it is used for

Alka-Seltzer contains acetylsalicylic acid, which has an analgesic, antipyretic, and anti-inflammatory effect and reduces the blood clotting potential.
Alka-Seltzer tablets are used for treating headache, toothache, menstrual pain, muscle and joint pain, and fever. Alka-Seltzer tablets are also used for pain or fever that occur in the case of common cold or the flu.

2. What you need to know before you use Alka-Seltzer

Do not use Alka-Seltzer:

-   if you are allergic to acetysalicylic acid or any of the other ingredients of this medicine (listed in section 6);
-   if you have an acute peptic or duodenal ulcer;
-   if you have a predisposition for bleeding;
-   if you have or have had asthma induced by salicylates or similar drugs (especially non-steroidal anti-inflammatory drugs);
-   if you have severe kidney, liver or heart failure;
-   if a treatment with 15 mg of methotrexate or more per week has been prescribed for you;
-   if you are in the last trimester of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.
Take special care with Alka-Seltzer:
-   if you have hypersensitivity to analgetic, anti-inflammatory, anti-rheumatics medicines or other allergens;
-   if you are prescribed anticoagulation treatment;
-   if you have a gastrointestinal ulcer, including chronic or recurrent ulcer disease or intestinal bleeding;
-   if you have chronic gastrointestinal disturbances or glucose-6-phosphate dehydrogenase deficiency;
-   if you have kidney or cardiovascular disorders (eg. renovascular disease, congestive heart failure, hypovolemia), you have undergone surgery, you have had sepsis or hemorrhages;
-   if you have metabolic disorder called glucose-6-phosphate dehydrogenase deficiency;
-   if you have liver function disorders;
-   if you have impaired uric acid excretion;
-   if you are pregnant (first or second trimester of pregnancy) or breast-feeding.
Already small doses of acetylsalicylic acid reduce excretion of uric acid. It might cause gout attacks in patients who have impaired uric acid secretion.
Acetylsalicylic acid might cause bronchospasm and elicit asthma attacks or other hypersensitivity reactions. The risk factors are underlying bronchial asthma, hay fever, nasal polyps (adenoid) or chronic respiratory disease.
Acetylsalicylic acid might predispose to bleeding during surgical procedures or after them (including smaller surgical procedures, eg. tooth extraction).
It is not recommended to use acetylsalicylic acid in children and adolescents under the age of 16 for febrile viral infections (incl. chickenpox, the flu), because it may induce Reye’s syndrome (life-threatening condition characterized by encephalopathy (impairment of central nervous system), abnormal hepatic function, prolonged vomiting as the first symptom). Reye’s syndrome is very rare, but potentially life-threatening condition which requires immediate medical attention.

Other medicines and Alka-Seltzer

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Alka-Seltzer must not be used if treatment with 15 mg of methotrexate or more per week has been prescribed for you.
Concomitant use of Alka-Seltzer might increase the effects and side-effects of the following medicines:
-   anti-coagulants (medicines that inhibit blood clotting);
-   non-steroidal anti-inflammatory drugs;
-   insulin and sulphonylurea preparations (diabetes medicines);
-   methodrexate (medicine used to treat malignant diseases, psoriasis and rheumatoid arthritis);
-   selective serotonin reuptake inhibitors (medicines used to treat depression);
-   digoxin (medicine used to treat heart failure);
-   valproic acid (medicine used to treat epilepsy).
Concomitant use of glucocorticoids (hormone medicines used to treat chronic and acute inflammations) reduce the effect of salicylates due to their increased excretion.
Concomitant use of Alka-Seltzer might decrease the effects of the following medicines:
-   diuretics (medicines that increase water excretion);
-   angiotensin-converting enzyme (ACE) inhibitors (medicines that lower blood pressure);
-   benzbromarone, probenecid (medicines that increase the excretion of uric acid).

Alka-Seltzer with alcohol

Consumption of alcohol while using the medicine increases the risk of gastrointestinal bleeding and prolongs the bleeding time.

Pregnancy and breast-feeding

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.
Using Alka-Seltzer is not recommended during pregnancy. During the first two trimesters of pregnancy, Alka-Seltzer effervescent tablets can only be used under the doctor’s prescription. Alka-Seltzer must not be used in the last trimester of pregnancy.
As adverse effects on the child have not been observed in case of occasional use, breast-feeding does not have to be discontinued as a rule. However, in case of regular use or large doses, breast-feeding must be discontinued expediently.

Driving and using machines

Alka-Seltzer does not affect the ability to drive or use machines.

3. How to use Alka-Seltzer

Always use this medicine exactly as your doctor or pharmacist has told you. Alka-Seltzer tablets should not be taken longer than 3-5 days without consulting a doctor.
Check with your doctor or pharmacist if you are not sure.
Adults and children from 12 years of age: 1-3 effervescent tablets as a single dose, which may be repeated in 4-8 hours. The maximum daily dose of 12 tablets should not be exceeded.

Children and adolescents:

Alka-Seltzer is not suitable to children under the age of 12 due to its high content of the active substance. It is recommended to use tablets with a lower acetylsalicylic acid content in children under 12 years of age. See section “Warnings and precautions”.
Alka-Seltzer is preferably administered after a meal. Alka-Seltzer tablets are dissolved in a glass of water before ingestion.

If you take more Alka-Seltzer tablets than you should

In the case of an overdose, you may experience dizziness, tinnitus (murmur/ringing in the ears), impaired hearing, sweating, nausea, vomiting, headache, and confusion; breathing may become fast and/or deep.
In the case of a severe poisoning, shortness of breath, respiratory arrest, very high fever, intestinal haemorrhage, cardiac arrthythmias, drop in blood pressure, cardiac arrest, unconsciousness or coma caused by sudden reduction in cerebral blood flow, seizures might occure.
Immediately talk to your doctor if signs of an overdose appear or if you suspect an overdose. Take the package of the medicine with you to the doctor.

If you forgot to take Alka-Seltzer tablets

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Signs of gastrointestinal irritation might occur, for example indigestion, stomach ache, rarely gastrointestinal inflammation and ulcer, which might very rarely result in the bleeding of the gastrointestinal ulcer and perforation.
The risk of bleeding is increased (bleeding occurring during or after surgical procedures, bruises, nosebleed, bleeding from urogenital tract and bleeding gums). Severe gastrointestinal and cerebral hemorrhages have occurred rarely and very rarely which in single cases might be life-threatening.
Due to bleeding acute and chronic anemia or iron-deficiency anemia might occur. The symptoms are exhaustion and paleness.
Hemolysis (breakdown of red blood cells) and hemolytic anemia have been reported in patients with severe glucose-6-phosphate dehydrogenase deficiency.
Renal impairment and acute kidney failure have been reported.
Hypersensitivity reactions (asthma, rash, hives, swelling, itching, runny nose, nasal congestion, changes in heart rate or rhythm, shortness of breath or breathing difficulties, very rarely anaphylactic reactions, incl. anaphylactic shock, which symptoms are sweating, nausea, bluish-red discoloration of skin or mucous membranes, significant drop in blood pressure, impaired consciousness, even coma etc.) might occur.
Dizziness and tinnitus (murmus/ringing in the ears) has occurred, which might be caused by an overdose.
Impaired liver function has been observed very rarely.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alka-Seltzer

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25 °C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Alka-Seltzer contains

-   The active substance is acetylsalicylic acid. One tablet contains 324 mg of acetylsalicylic acid.
-   The excipients are powdered anhydrous citric acid and anhydrous sodium bicarbonate.

What Alka-Seltzer looks like and contents of the pack

10 tablets in paper/PE/aluminium/Surlyn sachets.

Marketing Authorisation Holder:

UAB Bayer Sporto 18 LT-09238 Vilnius Lithuania

Manufacturer:

Bayer Bitterfeld GmbH Ortsteil Greppin Salegaster Chaussee 1
06803 Bitterfeld-Wolfen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Local representative of the Marketing Authorisation Holder in Estonia:

Bayer OÜ Lootsa 2, Tallinn Phone: +372 655 8565

This leaflet was last revised in November 2016

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