Roximstad 150 mg and 300 mg Roxithromycin Film Coated Tablets
What Roximstad Is And What Roximstad Used For?
Roximstad contains the active substance roxithromycin. Roxithromycin is a macrolide-type antibiotic. The bacteria’s protein production is prevented, and in this way, bacterial growth is prevented.
Roximstad used for
- Treatment of bacterial infection in the respiratory tract, including:
- Certain types of severe pneumonia ( pneumonia ) that are contagious in the community (community-acquired pneumonia )
- Treatment of urinary tract infections caused by a particular bacterium.
- Treatment of the following diseases in people who do not tolerate a type of medicine called beta-lactam antibiotics:
- Infection/inflammation of the tonsils (sore throat)
- Infection/inflammation of the throat ( pharyngitis )
- Sudden otitis media ( acute otitis media )
- Infection in the skin and surrounding tissues caused by bacteria, such as boils ( furunculosis ) and skin infections (pyoderma, impetigo, and erysipelas).
Roxithromycin contained in Roximstad may also be approved for treating other diseases 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.
What You Need To Know Before Using Roximstad
Do Not Use Roximstad
- If you are allergic to roxithromycin or any of the other ingredients of this medicine (listed in section 6)
- If you are allergic (hypersensitive) to macrolide-type antibiotics.
- If you take
- Cisapride (used to treat acid reflux)
- Ergot alkaloids (such as ergotamine or dihydroergotamine) are used to treat migraines.
- Pimozide (used to treat serious mental illness)
- Astemizole and terfenadine (medicines used to treat allergies )
- If you are born with a heart condition called QT prolongation.
- If someone in your family has a heart condition called QT prolongation. Your doctor will check for QT prolongation with ECG.
- If you have had a heart condition called QT prolongation.
Warnings And Cautions
Talk to your doctor or pharmacist before using Roximstad if you have or have had any illness, in particular, the following:
- If you have migraines and are taking ergot alkaloids (such as ergotamine and dihydroergotamine)
- If your heart muscle does not get enough blood (coronary heart disease)
- If you have a history of irregular heartbeat ( ventricular arrhythmia )
- If you have an imbalance in salt ( electrolyte ) or fluid level in your body. This includes:
- A low level of potassium in the blood ( hypokalaemia )
- A low level of magnesium in the blood (hypomagnesemia)
- If you have a slow heart rate ( bradycardia ) of less than 50 beats per minute.
- If you are taking medicines that can cause heart problems called QT prolongation, for example:
- Quinidine , procainamide , disopyramide , dofetilide, amiodarone (used to treat heart problems)
- Citalopram, tricyclic antidepressants (used to treat depression/mood disorders)
- Methadone (used to treat drug addiction)
- Antipsychotic drugs (eg phenothiazines)
- Drugs used to treat bacterial infections ( antibiotics ) that belong to a group called fluoroquinolones, e.g. moxifloxacin
- If you have a disease that is treated with medicines called protease inhibitors (eg telaprevir)
- If you are taking medicines used to treat fungal infections (eg ketoconazole, fluconazole, pentamidine)
- If you have mild to moderate liver disease or severe liver disease, you should not usually take Roximstad. For example, if you have a scarred and fibrous liver (cirrhotic liver) along with:
- Inflamed liver ( hepatitis ) or
- An accumulation of fluid in the abdomen ( ascites ). See also section 3 “how to use Roximstad”.
However, your doctor may decide that you need to take Roximstad to be able to treat your infection. In that case, your dose will be reduced. Your doctor will check your liver function regularly if:
- You have signs of liver disease
- You have previously had a poor liver function after treatment with roxithromycin.
If your liver function deteriorates during treatment, your doctor may ask you to stop taking Roximstad.
Pseudomembranous Colitis
This is an infection that causes inflammation in the colon. It can result in severe diarrhea lasting for days or weeks and occur during or after treatment. If you have these symptoms:
- Stop taking Roximstad immediately and contact your doctor
- Do not take medicines that slow down the bowel and reduce diarrhea.
Your doctor will prescribe another medicine to treat your symptoms.
Allergic (hypersensitivity) reactions
Some patients have had severe allergic reactions when taking roxithromycin. Reactions include a severe allergic reaction called anaphylaxis. Symptoms of anaphylaxis may include swelling of the skin, face, arms and legs, tongue or throat, and difficulty breathing. Sometimes these reactions can be life-threatening. If you have an allergic reaction:
- Stops taking Roximstad
- Contact your doctor or go to the nearest hospital immediately
Severe skin reactions
If a widespread, severe rash occurs, with symptoms such as:
- Blistering or scaling of the skin
- Signs of flu and fever ( Stevens-Johnson syndrome )
- General malaise, fever, chills and muscle aches ( toxic epidermal necrolysis )
- Red, scaly rash with lumps under the skin and blisters ( acute generalized exanthematous pustulosis ).
You should see a doctor immediately, as these skin reactions can be life-threatening.
Irregular heart rhythm ( arrhythmia )
If you get symptoms of an irregular or fast heartbeat during treatment:
- Stops taking Roximstad
- Contact your doctor immediately. He will check your heart rate with ECG.
A disorder that causes muscle weakness ( myasthenia gravis ): If you suffer from myasthenia gravis, your symptoms of myasthenia gravis may worsen. This can affect your breathing muscles, and your breathing may become too weak. If your symptoms worsen, stop taking Roximstad and contact a doctor immediately.
Blood and urine samples
If you need to take Roximstad for more than two weeks, your doctor will check you regularly:
- Your kidney function
- Your liver function
- Your blood.
Children and patients weighing less than 40 kg: Roximstad should not be used by:
- Children under 6 years
- Patients with a body weight of less than 40 kg
Children And Young People
Children and patients weighing less than 40 kg: Roximstad should not be used by:
- Children under 6 years
- patients with a body weight of less than 40 kg.
Other Medicines And Roximstad
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. Do not take Roximstad if you are already taking any of the following medicines (See section 2).
- Cisapride (used to treat nocturnal heartburn)
- Ergot alkaloids (such as ergotamine and dihydroergotamine) used to treat migraine headaches.
- Pimozide (used to treat mental illnesses such as schizophrenia)
- Astemizole and terfenadine (used to treat hay fever).
The effect of Roximstad may affect or be affected by the following drugs:
- Ciclosporin (used to prevent transplant rejection)
- Midazolam (used for its calming effect and to reduce anxiety)
- Anticoagulants (blood thinners, eg warfarin )
- Cardiac glycosides (stimulates the heart, eg digoxin )
- Disopyramide (heart medicine)
- Theophylline (used to treat asthma and lung disease)
- Bromocriptine (used to treat Parkinson’s disease and diseases where a decrease in a specific hormone ( prolactin ) is indicated)
- Rifabutin (used to treat tuberculosis )
- Drugs that can cause heart problems called QT prolongation eg:
- Quinidine , procainamide , disopyramide , dofetilide, amiodarone (used to treat heart problems)
- Citalopram, tricyclic antidepressants (used to treat depression/mood disorders)
- Methadone (used to treat drug addiction)
- Antipsychotic drugs (eg phenothiazines)
- Drugs used to treat bacterial infections ( antibiotics ) that belong to a group called fluoroquinolones, e.g. moxifloxacin
- If you have a disease that is treated with medicines called protease inhibitors (eg telaprevir)
- If you are taking medicines used to treat fungal infections (eg ketoconazole, fluconazole, pentamidine)
- Simvastatin or other statins (medicines used to treat high cholesterol ).
Birth control pills: The effect of pills can be impaired when you take Roximstad.
Roximstad With Food And Drink
Roximstad should be taken at least 15 minutes before a meal. This allows the medicine to be absorbed in a good way in the body. Take Roximstad with something to drink, such as a glass of water.
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.
Studies in animals have not shown any harmful effects of Roximstad. However, the use of Roximstad in pregnant or lactating women has not been studied.
If you are pregnant, you should only take Roximstad if your doctor thinks it is necessary.
Breast-feeding
Roximstad is excreted in human milk. If breastfeeding, you should only take Roximstad if your doctor thinks it is necessary.
Driving And Using Machines
When you take Roximstad, dizziness can sometimes occur. Impaired and blurred vision can also affect the patient’s ability to drive and use machines. If you experience these symptoms, do not drive or use machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
Roximstad Contains Milk Sugar (Lactose) And Sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free.’ is next to “sodium-free.”
How To Use Roximstad?
- Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- You should take Roximstad tablets at least 15 minutes before a meal with some liquid, e.g. water.
- Adults, the elderly, and children weighing more than 40 kg
- The recommended dose is 150 mg Roximstad twice daily (at 12-hour intervals).
- If you are being treated for pneumonia, your doctor may ask you to take Roximstad 300 mg once daily.
- If you have kidney or liver problems
- If you have impaired kidney function, dose one of Roximstad does not need to be adjusted.
- If you have mild to moderate hepatic impairment, your doctor will decide whether or not to take Roximstad.
- If you have a severe hepatic impairment, you should not normally take Roximstad. For example, if you have a scarred or fibrous liver ( liver cirrhosis ) along with:
- Hepatitis or accumulation of fluid in the abdomen ( ascites ). However, your doctor may decide that you need to take Roximstad to be able to treat your infection. In this case, you will receive half the usual dose one per day, ie. 150 mg roxithromycin.
- Use for children
- Roximstad tablets are not suitable for children under 6 years of age. Other forms of roxithromycin are available for young children, such as an oral suspension.
- Processing time
- Your doctor will tell you how long to take Roximstad. For some infections, the treatment should last for at least 10 days.
- You should usually take Roximstad for another 3 or 4 days after your symptoms have improved.
- It is important to always take the tablets for as long as your doctor prescribes them.
Use For Children And Adolescents:
Roximstad tablets are not suitable for children under 6 years of age. Other forms of roxithromycin are available for young children, such as an oral suspension.
If You Have Used Too Much Roximstad
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Symptoms of overdose are:
- Nausea
- Vomiting
- Diarrhea
- Headache
- Dizziness
Your doctor will treat the symptoms of overdose.
If You Forget To Use Roximstad
If you miss a dose, continue as before until the treatment is over. Do not take a double dose to compensate for a missed dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Roximstad Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Dosage once daily (1 x 300 mg Roximstad tablets) gives more side effects than twice daily (2 x 150 mg Roximstad tablets).
Discontinue treatment and contact your doctor immediately if you receive the following:
Uncommon roximstad side effects (may affect up to 1 in 100 people)
- Severe skin reactions such as
- Erythema multiforme. This can cause spots, red or purple, or areas with blisters.
Rare (may affect up to 1 in 1,000 people):
- Symptoms of angioedema (a life-threatening reaction), such as:
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing.
Has been reported (occurs in an unknown number of users):
- Inflammation of the intestine that causes abdominal pain or diarrhea (pseudomembranous colitis ).
- Severe skin reactions such as
- Toxic epidermal necrolysis (TEN). This can cause a red rash over many parts of the body and loss of the outer layer of the skin.
- Stevens-Johnson syndrome can cause red or purple rashes that spread and blisters, which eventually cause the top layer of skin to flake off. Other symptoms include fever, chills, headache, and fatigue.
- Exanthematous pustulosis is a red, scaly rash with bumps under the skin and blisters.
- Potentially fatal inflammation of the pancreas is characterized by abdominal pain, nausea, vomiting, diarrhea, fever, and shock ( hemorrhagic pancreatitis ).
- Severe allergic (hypersensitivity) reactions (anaphylactic shock ).
- SSA’sssevere decrease indecreaseber of white blood cells increases the risk of infection ( agranulocytosis ).
Roximstad can also cause the following side effects:
Consult your doctor at regular intervals as directed. This will help detect any side effects. Inform your doctor during routine examinations if you experience or have experienced a possible side effect.
Common (may affect up to 1 in 10 people):
- Stomach upset (nausea)
- Pain in the middle of the upper abdomen (epigastric pain)
- Headache
- Dizziness
- Upset stomach ( dyspepsia )
- Runny stools (diarrhea)
- Itching
Uncommon (may affect up to 1 in 10 people):
- Vomiting
- Severe constipation ( constipation )
- Weather voltage ( flatulence )
- Liver effects with elevated liver values
- Reddening of the skin
- Hives ( urticaria )
- Increase in certain white blood cells, detected by blood tests ( eosinophilia ).
Rare (may affect up to 1 in 1,000 people):
- Altered blood levels
- Allergic (hypersensitivity) reactions such as anaphylaxis
- Taste disorders ( dysgeusia ), including loss of sense of taste ( ageusia )
- Olfactory disorders (parosmia), including loss of sense of smell ( anosmia )
- Wheezing or difficulty breathing ( bronchospasm )
- Problems with bile flow from the liver. This causes a buildup of bile in the liver and liver damage (cholestatic hepatitis )
- Sudden inflammation of the liver ( hepatitis )
- Inflammation of the pancreas ( pancreatitis )
- Skin disease with redness, itching, and peeling of the skin ( eczema )
- Weakness
- Feeling uncomfortable
Has been reported (occurs in an unknown number of users):
- Resistant bacteria or fungi cause infection (if you take Roximstad for a long time)
- Decreased platelet count ( thrombocytopenia )
- Confusion
- To see or hear things that do not exist (hallucinations)
- Mental illness where you lose touch with reality ( psychosis )
- Abnormal sensations and ant crawling ( paresthesia )
- Impaired vision
- Vision problems (blurred vision)
- Irregular heartbeat ( QT prolongation)
- Rapid heartbeat ( ventricular tachycardia )
- Problems with conduction of heart rhythm ( Torsades de Pointes )
- Loss of appetite (anorexia)
- Yellowing of the skin or whites of the eyes (jaundice)
- Pruritus
- Severe muscle weakness ( myasthenia gravis )
- Low white blood cell count ( neutropenia )
- Purple or red pin-sized spots on the skin or mucous membranes caused by minor bleeding (purpura).
- Transient deafness
- Hearing loss
- A feeling of dizziness or vertigo ( vertigo )
- Tinnitus
How To Store Roximstad?
- Keep this medicine out of sight and reach of children.
- Do not store above 30 ° C.
- Do not use this medicine after the expiry date 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 that are no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Content Declaration
- The active substance is roxithromycin.
- One Roximstad 150 mg film-coated tablet contains 150 mg roxithromycin.
- One Roximstad 300 mg film-coated tablet contains 300 mg roxithromycin.
- The other ingredients in the tablet core are:
- Microcrystalline cellulose
- Colloidal anhydrous silica
- Croscarmellose sodium
- Poloxamer 188
- Provider
- Talc
- Magnesium stearate
- Other content topics in the film coating are:
- Lactose monohydrate
- Hypromellose
- Macrogol 400
- Titanium dioxide (E171)
What The Medicine Looks Like And The Contents Of The Pack
- Roximstad 150 mg is a round, white, film-coated tablet.
- Roximstad 300 mg is an oblong white capsule-shaped film-coated tablet with an off-white core and a score line on one side.
- Blister packaging of PVC and aluminum.
- Pack sizes:
- 150 mg: 5, 10, 12, 14, 16, 20, 28, 30, 50, 60, 90, 100, 250 and 500 tablets.
- 300 mg: 5, 6, 7, 10, 14, 16, 20, 28, 30, 50, 60, 90, 100, 250 and 500 tablets
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark