Ramoclav

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Ramoclav (Enhancin)

875 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic Acid
Ramoclav and Enhancin are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ramoclav and what is it 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 packaging and other information

1. What is Ramoclav and what is it used for

Ramoclav is an antibiotic that works by killing bacteria that cause infections.
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 the patient is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6)
• if the patient has ever had severe allergic reactions to any other antibiotic. These may include a rash or swelling of the face or neck.
• if the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with taking an antibiotic.

If any of the above circumstances apply to the patient, they should not take Ramoclav.In case of doubt, before starting treatment with Ramoclav, the patient should consult their doctor or pharmacist.
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Warnings and precautions

Before starting treatment with Ramoclav, the patient should discuss it with their doctor or pharmacist if they:

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

In case of doubt, whether the above applies to the patient, they should consult their doctor or pharmacist before starting treatment with Ramoclav.
In some cases, the doctor may order a test to determine the type of bacteria that caused the patient's infection. Depending on the results, the patient may receive Ramoclav in a different dose or a different medicine.

Conditions to watch out for

Taking Ramoclav may exacerbate the course of certain diseases or cause severe side effects, including allergic reactions, seizures, and colitis. The patient should be aware of whether certain symptoms have occurred during treatment with Ramoclav to minimize the risk of side effects. See "Conditions to watch out for" in section 4.

• 4.

Blood and urine tests

If the patient is to have blood tests (such as a red blood cell count or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Ramoclav. Ramoclav may affect the results of these tests.

Ramoclav and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about any medicines they plan to take.
If the patient is taking allopurinol (used to treat gout), they are more likely to experience skin allergic reactions.
If the patient is taking probenecid (used to treat gout), the doctor may decide to modify the dose of Ramoclav.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Ramoclav, additional blood tests may be necessary.
Ramoclav may affect the action of methotrexate (a medicine used to treat cancer and rheumatic diseases).
Ramoclav may affect the action of mycophenolate mofetil (a medicine used to prevent transplant rejection).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and operating machinery

Ramoclav may cause side effects that can impair the ability to drive or operate machinery. The patient should not drive or operate machinery unless they feel well.

3. How to take Ramoclav

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This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

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

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

Children with a body weight below 40 kg

Children under 6 years of age should preferably be treated with amoxicillin and clavulanic acid in the form of an oral suspension or sachets.
Before taking Ramoclav tablets in children with a body weight below 40 kg, the patient should consult their doctor or pharmacist.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Ramoclav or a different medicine.
• If the patient has liver disease, they should have blood tests more frequently to check how their liver is functioning.

Route and method of administration

• Tablets should be swallowed whole, with a glass of water, at the beginning of a meal or just before a meal.
• Between doses taken during the day, the patient should maintain equal, at least 4-hour intervals. The patient should not take 2 doses of the medicine within 1 hour.

Duration of treatment
The patient should not take Ramoclav for more than 2 weeks. If the patient still does not feel well, they should contact their doctor again.
The dividing line is intended only to facilitate breaking the tablet for easier swallowing, in case of problems with swallowing whole.

Taking a higher dose of Ramoclav than recommended

If the patient takes a higher dose of Ramoclav than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. The patient should consult their doctor as soon as possible. The patient should take the packaging of the medicine with them so that they can show it to the doctor.

Missing a dose of Ramoclav

If the patient misses a dose, they should take it as soon as possible. The patient should not take the next dose too early, but wait about 4 hours before taking the next dose.
The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Ramoclav

The patient should continue taking Ramoclav until the end of the treatment, even if they feel better. All doses of the medicine are necessary to combat the infection. If some bacteria survive, they may cause a recurrence of the infection.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Conditions to watch out for

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Allergic reactions

• rash
• vasculitis, which may appear as red or purple raised spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpit, or groin
• swelling, sometimes involving the face or mouth (angioedema), causing difficulty breathing, collapse. If any of these symptoms occur, the patient should contact their doctor immediately. The patient should stop taking Ramoclav.

Colitis

Colitis, causing watery diarrhea with blood and mucus, abdominal pain, and (or) fever.
If any of these symptoms occur, the patient should contact their doctor as soon as possiblefor advice.

Very common side effects

These may occur in more than 1 in 10 patients

• diarrhea (in adults)

Common side effects

These may occur in less than 1 in 10 patients

• fungal infection (candidiasis) of the vagina, mouth (thrush), skin folds
• nausea, especially when taking large doses → if this occurs, the patient should take Ramoclav before a meal
• vomiting
• diarrhea (in children)

Uncommon side effects

These may occur in less than 1 in 100 patients

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

Uncommon side effects that may be revealed by blood test results:

• increased activity of certain substances (enzymes) produced in the liver, which may indicate liver damage.

Rare side effects

These may occur in less than 1 in 1000 patients

• rash, which may take the form of blisters and look like small targets (dark spots in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme) if any of these symptoms occur, the patient should contact their doctor immediately.

Rare side effects related to blood test results:

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

Other side effects

Other side effects have occurred in a very small number of patients, but their exact frequency is not known.

• Allergic reactions (see above)

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• Colitis (see above)
• Meningitis (aseptic meningitis)
• Severe skin reactions: o Widespread rash, which may include blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis) o Widespread red rash, which may include small, pus-filled blisters (bullous exfoliative dermatitis) o Red, scaly rash with thickening of 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 an increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).

If any of the above symptoms occur, the patient should contact their doctor immediately.

• hepatitis
• jaundice caused by an increase in bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• interstitial nephritis
• prolonged blood clotting time
• restlessness
• seizures (in people taking high doses of Ramoclav or with kidney disease)
• black hairy tongue
• tooth discoloration (in children), which can usually be removed by brushing.

Side effects that may appear in the patient's blood or urine test results:

• significant decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Ramoclav

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store at a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
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Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ramoclav contains

• The active substances are amoxicillin and clavulanic acid. One film-coated tablet contains 1004.3 mg of amoxicillin trihydrate, which corresponds to 875 mg of amoxicillin, and 148.9 mg of potassium clavulanate, which corresponds to 125 mg of clavulanic acid.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethyl cellulose (type A), colloidal anhydrous silica, povidone K 30, butyl methacrylate copolymer, magnesium stearate, coating: macrogol 400, hypromellose 6cP, titanium dioxide (E 171), talc, macrogol 400.

What Ramoclav looks like and what the packaging contains

Film-coated tablets, white to off-white, capsule-shaped with the imprint "RX509" on one side and a dividing line on the other.
The packaging contains 14 or 21 tablets in a PVC/PVDC/Al blister pack in a polyester/Al/polyester/polyethylene bag with a desiccant sachet.
The patient should not swallow the desiccant found in the sachet inside the packaging.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Terapia S.A., Str. Fabricii nr. 124, Cluj Napoca, Romania

Manufacturer:

Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, Netherlands
Terapia SA, Str. Fabricii nr. 124, Cluj Napoca, Romania
ALKALOIDA Chemical Company Zrt., Kabay János u. 29., Tiszavasvári, 4440, Hungary
Ecopharm EOOD, 14 Cherni vrah Blvd., bl. 3, parter, 1421, Sofia, Bulgaria

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number: 12777/2019/04
12777/2019/07
12777/2019/09

Parallel import authorization number: 15/22 Date of leaflet approval: 10.01.2022

Medical advice

Antibiotics are used to treat bacterial infections. They are ineffective in treating 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 use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the risk of bacteria becoming resistant to antibiotics.
The antibiotic prescribed by the doctor is intended only to treat the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria, which could cause the antibiotic to stop working.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct number of days. The patient should read the instructions in the information about the medicine and if any of them are unclear, ask their doctor or pharmacist to explain them.
• 2. The patient should not take an antibiotic that has not been prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they have a similar infection.
• 4. The patient should not give their antibiotics to others.
• 5. If there are any leftover antibiotics after completing the treatment as directed by the doctor, the patient should return them to the pharmacy for proper disposal.

[Information about the trademark]
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