250 mg, 500 mg hard capsules 
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. Do not give it to others. It may harm them, even if they show symptoms 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 Amoxicillin Aurobindo is and what it is used for 
2. What you need to know before you use Amoxicillin Aurobindo   
3. How to use Amoxicillin Aurobindo 
4. Possible side effects 
5. How to store Amoxicillin Aurobindo 
6. Package contents and other information

What Amoxicillin Aurobindo is and what it is used for

What Amoxicillin Aurobindo is

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

What Amoxicillin Aurobindo is used for

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

What you need to know before you use Amoxicillin Aurobindo  

Do not take Amoxicillin Aurobindo

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

Warnings and cautions

Talk to your doctor or pharmacist before taking Amoxicillin Aurobindo.

  • 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 Aurobindo.

Blood and urine samples

If you are leaving:

  • urine tests ( glucose ) or blood tests to check liver function
  • estradiol samples (taken during pregnancy to check that the baby is developing normally)you should tell your doctor or pharmacist that you are taking Amoxicillin Aurobindo. Amoxicillin Aurobindo may affect test results.

Other medicines and Amoxicillin Aurobindo

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

Pregnancy and breastfeeding

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 Aurobindo 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.

Amoxicillin Aurobindo contains

Amoxicillin Aurobindo contains the azo dye azorubin (E122), which may cause allergic reactions.

3. How to use Amoxicillin Aurobindo

  • Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. The capsule should be swallowed unopened together with water.
  • 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 Aurobindo to give to your child.
  • 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 Aurobindo 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: 750 mg – 1 gram three times a day.
  • Urinary tract infection: 3 grams twice a day for 24 hours.
  • Lyme disease (an 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 along 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 be given a lower dose.

If you use more Amoxicillin Aurobindo than you should  

If you have taken too much Amoxicillin Aurobindo, you may have an upset stomach (nausea, vomiting, or diarrhea) or crystals in your urine, which may turn out to be cloudy urine or difficulty urinating. Talk to a doctor as early as possible. Take the medicine with you and show it to your doctor.

If you forget to take Amoxicillin Aurobindo

  • 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 Aurobindo?

  • Keep taking Amoxicillin Aurobindo 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, you should 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 Aurobindo for a long time. If you get cod, tell your doctor.

If you are taking Amoxicillin Aurobindo 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 Aurobindo and see a doctor straight away if you get any of the following serious side effects – you may need immediate medical treatment:

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 Aurobindo. 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 glands, and abnormal results from blood tests
  • (including increased white blood cell count ( eosinophilia ) and liver enzymes) (Drug reaction with eosinophilia and systemic symptoms (DRESS)).
  • flu-like symptoms with rash, fever, swollen glands, 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 Aurobindo 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 for 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 get any of these side effects, talk to your doctor. Treatment with Amoxicillin Aurobindo must be discontinued.

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.
  • 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 Aurobindo

Store in the original package

Do not store above 30 ° C

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 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 amoxicillin trihydrate equivalent to amoxicillin 250 mg and 500 mg respectively.

The other ingredients are microcrystalline cellulose and magnesium stearate. The capsule cover contains sodium lauryl sulfate, gelatin, and the dyes patent blue (E131), titanium dioxide (E171), yellow iron oxide (E172), and azorubin (E122). The ink contains shellac and black iron oxide (E172).

What the medicine looks like and the contents of the pack

250 mg capsule: reddish-brown/yellow, marked “A” and “85”.

500 mg capsule: reddish-brown/yellow, marked “A” and “86”.

Pack size: 7, 14, 21, 30, 50 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

Milpharm Ltd,

Ares, Odyssey Business Park, West End Road,

South Ruislip HA4 6QD

UK

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

For further information on this medicine, please contact your local representative

Orion Pharma AB, Danderyd

Medinfo@orionpharma.com

Muhammad Nadeem

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