OSPAMOX QUICKTAB 1000 mg x 14 tabl

OSPAMOX QUICKTAB 1000 mg x 14 tabl

Leaflet : patient information

Ospamox 1000 mg dispersible tablets

Ospamox 1000 mg dispersible tablets

amoxicillin/amoxicillin

What this leaflet contains:

1. What Ospamox is and what it is used for
2. What you need to know before you take Ospamox
3. How to take Ospamox
4. Possible side effects
5. How to store Ospamox
6. Package contents and additional information

1. What Ospamox is and what it is used for

What is Ospamox?

Ospamox is an antibiotic. The active substance is amoxicillin. It belongs to a group of medicines called "penicillins".

What Ospamox is used for

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

2. What you need to know before you take Ospamox

Do not take Ospamox

- if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6).

- if you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or throat.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Ospamox if you:

• you have glandular fever (high fever, sore throat, swollen lymph nodes and extreme tiredness)
• you have kidney problems
• you do not urinate regularly.

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

Blood or urine tests

If they do to you:

• Urine tests (urine glucose tests) or blood tests to monitor liver function
• Estriol tests (used during pregnancy to check if the baby is developing normally)

Tell your doctor or pharmacist that you are taking Ospamox. This is necessary because Ospamox can affect the results of these tests.

Other medicines and Ospamox

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

• If you take allopurinol (used to treat gout) with Ospamox, you may be more likely to get an allergic skin reaction.
• If you are taking probenecid (used to treat gout), your doctor may decide to adjust your dose of Ospamox.
• If you are taking medicines that prevent blood clots (such as warfarin), you may need to have additional blood tests.
• If you are taking other antibiotics (such as tetracycline) Ospamox may be less effective.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis) Ospamox may cause an increase in side effects.

Pregnancy and breastfeeding

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.

Driving and using machines

Ospamox can cause side effects and symptoms (such as allergic reactions, dizziness and seizures) that may make you unable to drive.

Do not drive or operate machinery if you feel unwell.

Ospamox contains aspartame, benzyl alcohol, benzyl benzoate, ethanol, sodium, sorbitol, sulfur dioxide

This medicine contains 5.2 mg of aspartame in each dispersible tablet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body can't get rid of it properly.

This medicine contains up to 0.60 mg of benzyl alcohol in each dispersible tablet. Benzyl alcohol can cause an allergic reaction. Ask your doctor or pharmacist for advice if you are pregnant, breastfeeding or have impaired liver or kidney function. This is because a large amount of benzyl alcohol can build up in your body, which can cause side effects (called 'metabolic acidosis'). Do not use for longer than a week in small children (under 3 years) unless recommended by a doctor or pharmacist.

This medicine contains up to 0.29 mg of benzyl benzoate in one dispersible tablet. Benzyl benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

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

This medicinal product contains less than 1 mmol sodium (23 mg) per dispersible tablet, which means it is essentially sodium-free.

This medicine contains 0.064 mg of sorbitol in each dispersible tablet.

This medicine contains 48 ng of sulfur dioxide. May rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Ospamox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Tablets can be used in two ways. First dissolve in water, then drink or simply take the tablet with water. The tablet can be broken for easier swallowing.
• Divide the doses evenly throughout the day, at intervals of at least 4 hours.

The usual dose is:

Children weighing less than 40 kg

All doses are determined depending on the child's body weight in kilograms.

• Your doctor will advise how much Ospamox you should give your baby or child.
• The usual dose is 40 mg to 90 mg for each kilogram of body weight per day, divided into two or three separate doses.
• The maximum recommended dose is 100 mg for each kilogram of body weight per day.

Adults, elderly patients and children with a body weight of 40 kg or more

The usual dose of Ospamox is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g, three times a day
• Urinary tract infections: 3 g, twice daily for 1 day
• Lyme disease (infection spread by parasites called ticks): Isolated erythema migrans (early stage-red or pink spherical rash): 4 g daily; Systemic manifestations (late stage for more serious symptoms or when the disease spreads throughout the body): up to 6 g daily.
• Stomach ulcer: one dose of 750 mg or 1 g, twice a day for 7 days, with other antibiotics and medicines for the treatment of stomach ulcers.
• To protect against heart infection during surgery: the dose may vary according to the type of surgery. It is possible to administer other medicines at the same time. Your doctor, pharmacist or nurse can give you more information.
• The maximum recommended daily dose is 6 g per day.

Kidney problems

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

If you have taken more Ospamox than you should

If you have taken more Ospamox than you should, signs may include stomach problems (nausea, vomiting or diarrhoea) or crystals in the urine, which may appear as cloudy urine or problems passing urine. See your doctor as soon as possible. Take the medicine to show the doctor.

If you forget to take Ospamox

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

How long should you take Ospamox?

• Keep taking Ospamox for as long as your doctor tells you, even if you feel better. You need every dose to fight the infection. If some bacteria survive, they can cause the infection to re-emerge.
• If you still do not feel well after your treatment is finished, you should visit the doctor again.

Candidiasis (a fungal infection of moist areas of the body that can cause inflammation, itching and a white discharge) may develop if Ospamox is taken for a long time. If this happens, inform your doctor.

If you take Ospamox for a long time, your doctor may order additional tests to check that your kidneys and liver are working properly and that your blood counts are normal.

If you have any further questions related to the use of this medicine, 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 Ospamox and see a doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

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

• allergic reactions, signs may include: itchy skin or rash, swelling of the face, lips, tongue, body, or difficulty breathing. They can be serious and sometimes fatal
• rash or small flat red round spots under the skin or bruising on the skin. This is due to inflammation of the blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems
• A delayed-type allergic reaction may occur, usually 7 to 12 days after taking Ospamox, some of the signs include: rash, high fever, joint pain, and enlarged lymph nodes, especially in the armpits
• a skin reaction known as 'erythema multiforme' where you may develop: itchy reddish-purple patches on the skin, especially on the palms of the hands or soles of the feet, 'hives-like' raised swollen areas of the skin, painful areas on the surface of the mouth , eyes and genitals. You may have a high fever and be very tired
• other severe skin reactions may include: changes in skin color, bumps under the skin, blistering, blisters with pus, peeling, redness, pain, itching, peeling. They may be associated with fever, headache and body aches
• flu-like symptoms with rash, fever, swollen glands, and blood test results that are outside the normal range (including elevated levels of white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
• fever, chills, sore throat or other signs of infection, or easy bruising. These may be signs of a blood cell problem
• the Jarisch-Herxheimer reaction , which develops during Ospamox treatment for Lyme disease and causes high fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon), accompanied by diarrhea (sometimes containing blood), pain and high fever
• serious side effects from the liver may occur. They were mostly seen in people who were treated for a long period of time, in men and in the elderly. You should tell your doctor immediately if you get:

o severe diarrhea with bleeding

o blistering, redness or bruising of the skin

o darker urine or pale stools

o yellowing of the skin or the whites of the eyes (jaundice). See also anemia below, which can lead to jaundice.

These reactions may occur while you are taking the drug or up to several weeks after you stop taking it.

If you experience any of the above reactions, stop taking the medicine and contact your doctor immediately.

Sometimes you may get less severe skin reactions such as:

• a slightly itchy rash (round, pink-red spots), "hives-like" swollen areas on the elbows, legs, palms, arms or feet. This reaction is uncommon (may affect up to 1 in 100 people).

Contact your doctor if you experience any of these reactions, as you will need to stop taking Ospamox.

Other possible side effects are:

Common (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhea.

Uncommon (may affect up to 1 in 100 people)

• vomiting.

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

• candidiasis (fungal infection of the vagina, mouth or skin folds). Your doctor or pharmacist may prescribe treatment for candidiasis
• kidney problems
• seizures (convulsions) seen in patients taking high doses or in patients with kidney problems
• dizziness
• hyperactivity
• crystals in the urine, which can be seen as cloudy urine, or difficulty or discomfort when urinating. Make sure you drink enough fluids to reduce the chance of these symptoms occurring
• stains may appear on the teeth, which usually disappear with brushing (this has been reported in children)
• the color of the tongue may change to yellow, brown or black and may appear "hairy"
• excessive destruction of red blood cells, causing a type of anemia. Signs include: tiredness, headache, shortness of breath, dizziness, paleness and yellowing of the skin and the whites of the eyes
• decrease in white blood cells
• lowering the number of cells involved in blood clotting
• blood may take longer than usual to clot. You may notice this if you have a nosebleed or cut yourself.

Not known (from the available data, the frequency cannot be determined):

• Inflammation of the protective membrane covering the brain (aseptic meningitis)

Reporting adverse reactions

If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the national reporting system to the Executive Medicines Agency, 8 Damyan Gruev St., 1303 Sofia, phone: +35928903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store Ospamox

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

To be stored below 25°C.

Store in original packaging to protect from moisture.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Ospamox contains

• The active substance is amoxicillin. Each dispersible tablet contains 1000 mg of amoxicillin as trihydrate.

The other ingredients are: peach-apricot flavoring powder (contains benzyl benzoate, ethanol, sorbitol, sulfur dioxide), orange flavoring powder (contains benzyl alcohol), magnesium stearate (E470b), aspartame (E951), croscarmellose sodium , mannitol (E421), talc (E553b), colloidal anhydrous silica (E551), microcrystalline cellulose (E460), maltodextrin, hydroxypropyl pea starch, pregelatinized, titanium dioxide (E171).

What Ospamox looks like and contents of the pack

1000 mg dispersible tablets

The tablets are oblong, biconvex, white to yellowish white, approximately 10 x 22 mm in size, scored

The dispersible tablets are packed in PVC/PVDC/Alu blisters and in cardboard packs.

Packaging:

2, 6, 8, 10, 12, 14, 16, 20, 24, 30, 100 and 1000 dispersible tablets.

Not all packages may have been released.

License holder

Sandoz dd

Verovškova 57

1000 Ljubljana

Slovenia

Manufacturer

Sandoz GmbH

Biochemiestrasse 5

A-6250 Kundl

Austria

This medicinal product is authorized for use in the EEC member countries under the following names :

Date of last revision of leaflet :

10/2020

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