Ramoclav

Package Leaflet: Information for the User

Ramoclav, 875 mg + 125 mg, film-coated tablets
Amoxicillin + Clavulanic Acid

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, 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 pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.

Contents of the Package Leaflet

• 1. What Ramoclav is and what it is used for
• 2. Important information before taking Ramoclav
• 3. How to take Ramoclav
• 4. Possible side effects
• 5. How to store Ramoclav
• 6. Contents of the pack and other information

1. What Ramoclav is and what it is used for

Ramoclav is an antibiotic that works by killing bacteria that cause infections. It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins, which can sometimes be stopped from working (inactivated). The other active ingredient (clavulanic acid) stops this from happening.
Ramoclav is used in adults and children to treat:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections.

2. Important information before taking Ramoclav

When not to take Ramoclav:

If any of these apply to you, do not take Ramoclav.If you are not sure, talk to your doctor or pharmacist before taking Ramoclav.

Warnings and precautions

Before taking Ramoclav, talk to your doctor or pharmacist if you:

• have infectious mononucleosis
• are being treated for liver or kidney disease
• have irregular urine output.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Ramoclav.
In some cases, your doctor may want to do a test to find out what type of bacteria is causing your infection. Depending on the results, you may be given Ramoclav in a different dose or a different medicine.

Conditions to watch for

Taking Ramoclav can make some conditions worse or cause serious side effects, including allergic reactions, seizures, and colitis. You should be aware of certain symptoms to reduce the risk of side effects. See “Conditions to watch for” in section 4.

Blood and urine tests

If you are going to have a blood test (such as a red blood cell count or liver function test) or a urine test (for glucose), tell your doctor or nurse that you are taking Ramoclav. Ramoclav can affect the results of these tests.

Ramoclav with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, or might take.
If you are taking allopurinol (for gout), you may be more likely to get a skin rash.
Probenecid (for gout) may reduce the excretion of amoxicillin and is not recommended.
If you are taking blood-thinning medicines (such as warfarin), you may need to have extra blood tests.
Methotrexate (for cancer or severe psoriasis) can be affected by penicillins, which can cause increased side effects.
Ramoclav may affect the way mycophenolate mofetil (a medicine used to prevent transplant rejection) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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

Ramoclav can cause side effects that may affect your ability to drive or use machines. Do not drive or use machines unless you feel well.

Ramoclav contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially sodium-free.

3. How to take Ramoclav

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

Adults and children over 40 kg

• Usual dose - 1 tablet twice a day
• Larger dose - 1 tablet three times a day

Children under 40 kg

Children under 6 years should be treated with amoxicillin and clavulanic acid oral suspension or sachets.
Before taking Ramoclav tablets in children under 40 kg, consult a doctor or pharmacist. The tablets are not suitable for children under 25 kg.

Patients with kidney and liver problems

• If you have kidney problems, your doctor may need to adjust your dose.
• If you have liver problems, you may need to have more frequent blood tests to check how your liver is working.

How to take Ramoclav

• Swallow the tablets whole with a glass of water, with food.
• The tablets can be broken in half to make them easier to swallow. Take both halves at the same time.
  Keep at least a 4-hour gap between doses. Do not take 2 doses in 1 hour.
• Do not take Ramoclav for more than 2 weeks. If you still feel unwell, go back to see your doctor.

Taking too much Ramoclav

If you take more Ramoclav than you should, you may feel sick or be sick (nausea or vomiting), have diarrhoea, or have fits (seizures). Talk to a doctor straight away. Take the medicine pack with you.

Missing a dose of Ramoclav

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

Stopping Ramoclav

Keep taking Ramoclav until the course is finished, even if you feel better. If you stop taking the medicine too soon, the infection may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ramoclav can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:

Conditions to watch for

Allergic reactions

• rash
• inflammation of blood vessels (which can be seen as red or purple raised spots on the skin, but can also affect other parts of the body)
• fever, joint pain, swollen lymph nodes in the neck, armpit or groin
• swelling, sometimes affecting the face or throat (angioedema), which can cause difficulty breathing, collapse
• chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).

If you get any of these symptoms, stop taking Ramoclav and see a doctor straight away.

Colitis

Colitis (inflammation of the colon), which can cause watery diarrhoea, blood and mucus in the stool, abdominal pain and (or) fever.

Acute pancreatitis

If you have severe, persistent stomach pain, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

DIES has mainly occurred in children taking amoxicillin and clavulanic acid. It is a type of allergic reaction, with recurring vomiting (1 to 4 hours after taking the medicine) as the leading symptom. Further symptoms can include abdominal pain, lethargy, diarrhoea, and low blood pressure.
If you get any of these symptoms, see a doctor straight away.

Very common side effects (may affect more than 1 in 10 people)

• diarrhoea (in adults)

Common side effects (may affect up to 1 in 10 people)

• fungal infections (such as thrush)
• nausea, especially when taking high doses → if this happens, take Ramoclav with food
• vomiting
• diarrhoea (in children)

Uncommon side effects (may affect up to 1 in 100 people)

• rash, itching
• raised, itchy, red patches on the skin (hives)
• indigestion
• dizziness
• headache

Uncommon side effects that may show up in blood tests:

• increased levels of some substances (enzymes) produced by the liver, which can be a sign of liver damage.

Rare side effects (may affect up to 1 in 1,000 people)

• rash, which can blister and look like targets (with a red centre, white edges, and red surrounding ring - erythema multiforme) if you get any of these symptoms, see a doctor straight away.

Rare side effects that may show up in blood tests:

• low numbers of blood cells involved in clotting
• low numbers of white blood cells.

Frequency not known (cannot be estimated from the available data)

• Allergic reactions (see above)
• Colitis (see above)
• Inflammation of the membranes around the brain and spinal cord (aseptic meningitis)
• Severe skin reactions: o Widespread rash, with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis) o Widespread red rash, with small, pus-filled bumps (pustular psoriasis) o Red, scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis) o Flu-like symptoms with a rash, fever, swollen lymph nodes, and abnormal blood test results [including increased numbers of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS) o Rash with target-shaped blisters (linear IgA dermatosis).

If you get any of these symptoms, see a doctor straight away.

• inflammation of the liver
• jaundice (yellowing of the skin and whites of the eyes) caused by a build-up of bilirubin (a substance produced by the liver) in the blood
• inflammation of the kidney tubules
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Ramoclav or with kidney problems)
• black, hairy tongue
• overgrowth of non-susceptible bacteria.

Side effects that may show up in blood or urine tests:

• severe reduction in the number of white blood cells
• low numbers of red blood cells (haemolytic anaemia)
• crystals in the urine, which can cause acute kidney damage.

Reporting 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 via the national reporting system listed in the website.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramoclav

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. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package, to protect from light.
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 protect the environment.

6. Contents of the pack and other information

What Ramoclav contains

• The active substances are amoxicillin and clavulanic acid. One film-coated tablet contains 1004.3 mg amoxicillin trihydrate, equivalent to 875 mg amoxicillin, and 148.9 mg potassium clavulanate, equivalent to 125 mg clavulanic acid.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), silica colloidal anhydrous, povidone K30, butyl methacrylate copolymer, magnesium stearate, macrogol 400, Opadry 03B58965 White: (hypromellose 6cP, titanium dioxide (E171), talc, macrogol 400).

What Ramoclav looks like and contents of the pack

White to off-white, capsule-shaped, film-coated tablets with “RX509” engraved on one side and a score line on the other.
The pack contains 14 or 21 tablets in a PVC/PVDC/Al blister pack in a sachet (polyester/polyethylene/aluminium/polyester) with a desiccant sachet containing 1 g of desiccant.
Do not swallow the desiccant.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
Poland

Manufacturer

Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Alkaloida Chemical Company Zrt.
Kabay János u. 29., Tiszavasvári, 4440
Hungary
Terapia S.A.
Str. Fabricii nr. 124
400 632 Cluj-Napoca
Romania
Ecopharm EOOD
14 Cherni vrah Blvd., bl.3, parter
1421 Sofia
Bulgaria
Date of last revision of the leaflet:28.06.2023

Medical Advice

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive and even multiply despite the antibiotic treatment.
Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help reduce the risk of bacteria becoming resistant to antibiotics.
The antibiotic prescribed by your doctor is for your current infection only. Paying attention to the following advice will help prevent the development of resistant bacteria that could stop the antibiotic from working:

• 1. It is very important to take the antibiotic at the right dose, at the right time, and for the right number of days. Read the instructions in the patient information leaflet and if you are not sure, ask your doctor or pharmacist to explain them to you.
• 2. You must not take an antibiotic that has not been prescribed for you. You should only take it for the infection it was prescribed for.
• 3. You must not take an antibiotic prescribed for someone else, even if they have a similar infection.
• 4. Do not give your antibiotic to anyone else.
• 5. If you have any antibiotic left over after you have finished your course of treatment, take it to your pharmacist for disposal.