750 mg, 1 g dispersible tablet 
amoxicillin

Read all of this leaflet carefully before you start using 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 you will find information about: 
1. What Amoxicillin Sandoz is and what it is used for 
2. What you need to know before you use Amoxicillin Sandoz 
3. How to use Amoxicillin Sandoz 
4. Possible side effects 
5. How to store Amoxicillin Sandoz 
6. Contents of the pack and other information 

What Amoxicillin Sandoz is and what it is used for

What Amoxicillin Sandoz is

Amoxicillin Sandoz is an antibiotic. The active substance is amoxicillin, which belongs to the group of medicines “penicillins”.

What Amoxicillin Sandoz is used for

Amoxicillin Sandoz is used for treating infections caused by bacteria in different parts of the body. Amoxicillin Sandoz can also be used in combination with other medicines to treat stomach ulcers.

Amoxicillin contained in Amoxicillin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Amoxicillin Sandoz

Do not take Amoxicillin Sandoz

  • if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6)
  • if you have previously had an allergic reaction to any antibiotic. For example, there may be a rash or swelling of the face or throat.

Do not take Amoxicillin Sandoz if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amoxicillin Sandoz.

Warnings and cautions

Talk to your doctor or pharmacist before taking Amoxicillin Sandoz if you:

  • have glandular fever (fever, sore throat, swollen lymph nodes, and severe fatigue)
  • have kidney problems
  • do not urinate periodically.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amoxicillin Sandoz.

Blood and urine samples

If you are leaving:

  • urine tests ( glucose ) or blood tests to check liver function
  • estriol samples (taken during pregnancy to check that the baby is developing normally)

you should tell your doctor or pharmacist that you are taking Amoxicillin Sandoz. Amoxicillin Sandoz may affect test results.

Other medicines and Amoxicillin Sandoz

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

  • If you take allopurinol (for gout ) together with Amoxicillin Sandoz, the risk of having an allergic skin reaction may increase.
  • If you are taking probenecid (for gout ), your doctor may change your dose of amoxicillin Sandoz.
  • If you are taking medicines to prevent blood clots (eg warfarin ), you may need to submit additional blood samples.
  • Taking other antibiotics (eg tetracycline ) may make Amoxicillin Sandoz less effective.
  • If you are taking methotrexate (used to treat cancer and severe psoriasis ), Amoxicillin Sandoz may increase the 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.

Driving and using machines

Amoxicillin Sandoz can have side effects and the symptoms (such as allergic reactions, dizziness, and cramps) can make you unsuitable as a driver.

Do not drive or use machines unless you are feeling well.

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 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.

Amoxicillin Sandoz contains aspartame, benzyl alcohol, benzyl benzoate, ethanol, sodium, sorbitol, and sulfur dioxide

750 mg dispersible tablet:

This medicine contains 3.9 mg of aspartame per dispersible tablet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.

This medicine contains no more than 0.45 mg of benzyl alcohol per dispersible tablet. Benzyl alcohol can cause allergic reactions. If you are pregnant or breast-feeding or if you have impaired liver or kidney function, consult your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ). Do not use this medicine for more than 1 week in newborns (younger than 3 years) unless your doctor or pharmacist has recommended it.

This medicine contains no more than 0.22 mg of benzyl benzoate per dispersible tablet. Benzyl benzoate may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dispersible tablet.

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

This medicine contains 0.048 mg sorbitol per dispersible tablet.

This medicine contains 36 nanograms of sulfur dioxide. May in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.

1 g dispersible tablet:

This medicine contains 5.2 mg of aspartame per dispersible tablet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.

This medicine contains no more than 0.60 mg of benzyl alcohol per dispersible tablet. Benzyl alcohol can cause allergic reactions. If you are pregnant or breast-feeding or if you have impaired liver or kidney function, consult your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ). Do not use this medicine for more than 1 week in newborns (younger than 3 years) unless your doctor or pharmacist has recommended it.

This medicine contains no more than 0.29 mg of benzyl benzoate per dispersible tablet. Benzyl benzoate may increase the risk of jaundice (yellowish skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dispersible tablet.

This medicine contains less than 1 mmol (23 mg) sodium per dispersible

tablet ie is almost “sodium-free”.

This medicine contains 0.064 mg sorbitol per dispersible tablet.

This medicine contains 48 nanograms of sulfur dioxide. May in rare cases cause severe hypersensitivity reactions and convulsions in the trachea.

3. How to use Amoxicillin Sandoz

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

  • The tablets can be used in two ways. You can either swallow the tablets with water or first dissolve the tablets in water and then drink them. The tablets can be divided to facilitate swallowing.
  • Distribute the doses evenly throughout the day at least 4 hours apart.

The usual dose is:

Children weighing less than 40 kg

All doses are calculated based on the child’s body weight in kg.

  • Your doctor will tell you how much Amoxicillin Sandoz to give to your baby or baby.
  • The usual dose is 40-90 mg per kg body weight in one day, divided into two or three doses.
  • The highest recommended dose is 100 mg per kg of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more

The usual dose of Amoxicillin Sandoz is 250-500 mg three times a day, or 750 mg-1 gram every 12 hours, depending on the severity and type of infection.

  • Serious infection: 750mg- 1 gram three times a day.
  • Urinary tract infection: 3 grams twice a day for 24 hours.
  • Borrelia ( infection spread by ticks ): Occasional erythema migrans (early stage – a red or pink circular rash): 4 grams per day. For systemic symptoms (late-stage – for more severe symptoms or when the disease spreads in the body): Up to 6 grams per day.
  • Gastric ulcer: A dose of 750 mg or 1 gram twice daily for 7 days with other antibiotics and medicines for gastric ulcer.
  • To prevent heart infection during surgery: The dose varies depending on the type of surgery. Other medicines can also be given at the same time. A doctor, pharmacist, or nurse can give you more information.
  • The highest recommended dose is 6 grams per day.

Kidney problems

If you have kidney problems, you may receive a lower dose than the usual dose.

If you take more Amoxicillin Sandoz than you should

If you forget to take Amoxicillin Sandoz

  • If you forget to take a dose, take it as soon as you remember.
  • Do not take the next dose too soon, but wait about 4 hours before taking the next dose.
  • Do not take a double dose to make up for a forgotten dose.

How long should you take Amoxicillin Sandoz?

  • Keep taking Amoxicillin Sandoz for as long as your doctor tells you, even if you feel better. All doses are needed to fight infection one. If some bacteria survive, the infection can return.
  • If you still do not feel well when the treatment is over, see a doctor again.

Cod (a fungal infection that can occur in moist areas of the body and cause soreness, itching, and a white discharge) can develop if you use Amoxicillin Sandoz for a long time. If you get cod, tell your doctor.

If you are taking Amoxicillin Sandoz for a short period of time, your doctor may want to take extra samples to check that your kidneys, liver, and blood are functioning normally.

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

4. Possible side effects

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

Stop taking Amoxicillin Sandoz and see a doctor immediately if you get any of the following serious side effects – you may need immediate medical attention:

The following side effects are very rare (may affect up to 1 in 10,000 people)

  • Allergic reactions, which may manifest as itching or rash, swelling of the face, lips, tongue, or body, or difficulty breathing. These can be serious and deaths have occurred.
  • Rash or flat, pin-sized red round dots under the skin surface, or bruises. These are caused by an inflammation of the walls of the blood vessels due to an allergic reaction. Joint pain ( arthritis ) and kidney problems can occur at the same time.
  • Delayed allergic reaction, which usually occurs 7 to 12 days after taking Amoxicillin Sandoz. Some of the signs of such a reaction are rash, fever, joint pain, and enlarged lymph nodes, especially in the armpits.
  • A skin reaction called “erythema multiforme”, when you can get itchy reddish-purple spots on the skin, especially on the palms and soles of the feet, hives-like raised swellings in the skin, sore areas in the oral cavity, eyes, and genitals. You may get a fever and feel very tired.
  • Other serious skin reactions may include skin discoloration, lumps under the skin, blisters, blisters, scaling, redness, pain, itching, and flaky skin. Fever, headache, and body aches can occur at the same time.
  • Flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal results from blood tests (including increased white blood cell count [eosinophilia] and liver enzymes) (drug reaction with eosinophilia and systemic symptoms [DRESS]).
  • Fever, chills, sore throat, and other signs of infection, or you can easily get bruises.
  • This may be a sign that the blood cells are affected. The Janisch-Herxheimer reaction may occur where Lyme disease is treated with amoxicillin Sandoz and cause fever, chills, headache, muscle aches, and rash.
  • Inflammation of the colon with diarrhea (sometimes mixed with blood), pain, and fever.
  • Serious liver side effects may occur. They mainly affect people who are treated for a long time, men and the elderly. You must tell your doctor immediately if you get:
    • severe diarrhea with bleeding
    • blisters or redness on the skin, or bruising
    • darker urine or lighter stools
    • yellowing of the skin or whites of the eyes (jaundice). Also read about anemia below, which can cause jaundice.

These side effects may occur during treatment or even several weeks afterward.

If you get any of the above side effects, stop taking the medicine and see a doctor immediately.

Occasionally, minor skin reactions may occur, such as:

  • Slightly itchy rash (round, pinkish spots), hives-like swollen areas on forearms, legs, palms, hands, or feet. This is less common (may affect up to 1 in 100 people).

If you experience any of these side effects are, speak with your doctor. Treatment with Amoxicillin Sandoz must be stopped.

Other possible side effects are:

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

  • rash
  • nausea
  • diarrhea.

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

  • vomiting.

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

  • Cod (a yeast infection in the vagina, mouth, or skin folds). Doctors or pharmacists can give you medicines for cod.
  • Kidney problems
  • Cramps. Occurs in people who take high doses or have kidney problems.
  • Dizziness
  • Hyperactivity
  • Crystals in the urine, which turn out to be cloudy urine, or difficulty or pain when urinating. Be sure to drink plenty of fluids to reduce the risk of developing such symptoms.
  • Teeth may become discolored but usually return to normal appearance when brushing teeth (this has been reported in children)
  • The tongue may discolor and turn yellow, brown, or black and have a hairy appearance
  • Severe breakdown of red blood cells that cause a certain type of anemia ( anemia). Signs of this are fatigue, headache, shortness of breath, dizziness, paleness, and yellowish skin and whites of the eyes.
  • Low white blood cell count
  • A low number of blood cell types involved in blood coagulation
  • It may take longer than normal for the blood to coagulate. You may notice this if you get nosebleeds or cut yourself.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Amoxicillin Sandoz

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP or EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original package. Moisture sensitive.

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 amoxicillin. Each dispersible tablet contains 750 mg of amoxicillin (as trihydrate). Each dispersible tablet contains 1 g of amoxicillin (as trihydrate).
  • The other ingredients are powdered peach-apricot flavoring (containing benzyl benzoate, ethanol, sorbitol, sulfur dioxide), powdered orange flavoring (containing benzyl alcohol), magnesium stearate (E470b), aspartame (E951), croscarmellose sodium, mannitol (E421), talc (E553b), anhydrous colloidal silica (E551), microcrystalline cellulose (E460), maltodextrin, soluble starch, titanium dioxide (E171).

What the medicine looks like and the contents of the pack

750 mg dispersible tablet :

The tablet is oblong, biconvex, white to off-white, approximate size 9 x 20 mm, scored.

1 g dispersible tablet :

The tablet is oblong, biconvex, white to off-white, approximate size 10 x 22 mm, scored.

The dispersible tablets are packaged in PVC / PVDC / Al blisters and are in a carton.

Pack sizes:

750 mg dispersible tablet: 4, 10, 12, 14, 20, 24, 30, 1,000 dispersible tablets

1 g dispersible tablet:  2, 6, 8, 10, 12, 14, 16, 20, 24, 30, 100, 1,000 dispersible tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder 

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

Muhammad Nadeem

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