20 mg / ml, oral suspension
What Rifadin is and what it is used for
Rifadin is a drug that counteracts the tubercle bacterium. Rifadin should always be combined with another tuberculosis agent.
Rifadin is used to treat tuberculosis.
What you need to know before using Rifadin
Do not use Rifadin
- if you are allergic to rifampicin or rifampicin-like medicines (rifamycins) or any of the other ingredients of this medicine (listed in section 6)
- if you have jaundice
- if you are taking any antiviral medicines from the group of protease inhibitors (eg fosamprenavir, indinavir, lopinavir / ritonavir, nelfinavir, saquvinavir, atazanavir, tipranavir and darunavir)
- if you are taking a medicine for hepatitis C (eg daclatasvir, simeprevir, sofosbuvir, and telaprevir)
- if you are taking an antifungal medicine called voriconazole
- if you are taking any of the heart medicines nifedipine or nimodipine
- if you are using the malaria medicine artemether-lumefantrine
Warnings and cautions
Talk to your doctor before using Rifadin if you:
- suffers from liver disease
- have previously had pneumonia (interstitial lung disease/pneumonitis)
- has increased turnover of porphyrins (a type of substance found in the liver)
- have problems with bleeding or easily get bruises
Tell your doctor immediately while taking this medicine:
- if you develop new or sudden worsening of shortness of breath, possibly with dry cough or fever that does not respond to antibiotic treatment. These can be symptoms of pneumonia (interstitial lung disease/pneumonitis) and can lead to severe respiratory problems due to fluid retention in the lungs and disrupt normal breathing, which can lead to life-threatening conditions.
- If a widespread, severe rash occurs, with symptoms such as blistering or scaling of the skin, as well as signs of flu and fever ( Stevens-Johnson syndrome ), general malaise, fever, chills and muscle aches ( toxic epidermal necrolysis ), or 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.
- If your symptoms of tuberculosis recur or get worse (see section 4. Any side effects ), you should see a doctor immediately.
Rifadin may discolor teeth, urine, tear fluid, and cough (discolors yellow, orange, red, brown) due to its color. Soft contact lenses can in some cases be discolored.
Tell your doctor that you are using Rifadin if you are going to have laboratory tests or an X-ray examination of the gallbladder. Other test methods may need to be used.
Other medicines and Rifadin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies to both prescription and over-the-counter medicines.
Rifadin should not be given concomitantly with certain medicines, see section Do not use Rifadin.
Rifadin may affect the effectiveness of certain medicines against:
- Viral infections (eg zidovudine, efavirenz, daclatasvir, simeprevir, sofosbuvir, maraviroc, nevirapine, raltegravir)
- Fungi ( ketoconazole , itraconazole, fluconazole , terbinafine)
- Bacterial infections (chloramphenicol, clarithromycin, doxycycline, telithromycin, moxifloxacin, metronidazole ( intravenous ), trimethoprim, cefazolin)
- Bacterial infections (dapsone): If you take dapsone with rifampicin, it can cause hematological toxicity including a decrease in the bone marrow and blood cells, and methemoglobinemia (decrease in oxygen in your blood caused by changes in red blood cells )
- Pain (morphine, methadone, oxycodone, paracetamol, etoricoxib)
- Epilepsy ( phenytoin , lamotrigine, hexobarbital, carbamazepine, valproate )
- Heart problems, e.g. high blood pressure (verapamil, digoxin , nifedipine, nimodipine, isradipine, disopyramide , propafenone , propranolol, metoprolol , diltiazem , amlodipine and losartan )
- Blood clots, ie blood thinners ( warfarin , clopidogrel)
- Malaria (atovaquone, quinine, artemeter / lumefantrine)
- Rejection of organs after transplantation (cyclosporine, tacrolimus, sirolimus, everolimus)
- Sleep problems and anxiety ( diazepam, zolpidem, zopiclone, buspirone)
- Depression (nortriptyline, amitriptyline)
- Psychosis ( haloperidol , clozapine, aripiprazole)
- High blood fats ( simvastatin )
- Diabetes (glibenclamide, glipizide, pioglitazone)
- Inflammation in the body, so-called corticosteroids (eg prednisolone )
- Cancer (irinotecan, tamoxifen, toremifen, imatinib, gefitinib, dasatinib, lapatinib, nilotinib, temsirolimus, pazopanib, erlotinib, sunitinib, sorafenib)
- Nausea / vomiting (ondansetron)
- Asthma (theophylline)
- Tuberculosis ( isoniazid )
- Hypothyroidism (levothyroxine)
- Occasional heartburn and acid reflux (ranitidine)
Also, consult a doctor if you are using birth control pills as the effect of these may be weakened. Other methods of contraception are recommended during treatment.
Agents for heartburn and acid reflux (antacids) reduce the effect of Rifadin and therefore Rifadin should be taken no later than 1 hour before these.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
There is a risk that the fetus is affected.
Rifadin passes into breast milk but is unlikely to affect breastfed infants.
Driving and using machines
Rifadin has no known effects on driving or using machines.
Rifadin contains sucrose
Due to the sugar content of the oral suspension, teeth should be brushed with fluoride toothpaste twice daily.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
At doses above 12.5 ml, the suspension contains more than 5 g of sucrose. This should be considered in patients with diabetes mellitus.
Rifadin contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.
How to use Rifadin
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor who adapts it for you.
The recommended dose is 10 mg/kg body weight once daily.
Rifadin should be taken on an empty stomach, preferably ½-1 hour before or 2 hours after a meal.
The oral suspension should be shaken before use.
If you use more Rifadin than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Rifadin
Do not take a double dose to make up for a forgotten dose.
If you stop taking Rifadin
Do not stop treatment without talking to your doctor first. If treatment is stopped too soon, the infection can flare up again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately if you get any of the following side effects:
- Reduced white blood cell count: If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication. (Occurs in an unknown number of users)
- DRES syndrome is a rare but serious and acute drug reaction with symptoms such as fever, rash, enlarged lymph nodes, and liver damage. (Occurs in an unknown number of users)
- An extremely severe allergic reaction with skin rash is usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals ( Stevens-Johnson syndrome ). (Occurs in an unknown number of users)
- Severe skin damage (skin detachment of the epidermis and superficial mucous membranes) (Occurs in an unknown number of users)
- Red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ) (Occurs in an unknown number of users)
- Intestinal inflammation with severe and/or bloody diarrhea that occurs during or after treatment with Rifadin. (Occurs in an unknown number of users)
- Bleeding and disorders in how the blood clots (coagulates): begins to bleed more easily or bleeds longer than usual, bruises more easily (Occurs in an unknown number of users)
- Inflammation of the lungs (interstitial lung disease/pneumonitis): Tell your doctor immediately if you develop a new or sudden worsening of shortness of breath, possibly with cough or fever (Occurs in an unknown number of users)
The following side effects may also occur:
Common (may affect up to 1 in 10 people)
- Elevated liver values
- Reduction in the number of platelets (small bleeds in the skin and mucous membranes)
- Vomiting, nausea.
- Paradoxical drug reaction: Symptoms of tuberculosis may recur or new symptoms may appear after early improvement during treatment. Paradoxical reactions have been reported as early as two weeks and as late as 18 months after the start of tuberculosis treatment. Paradoxical reactions are usually associated with fever, swollen lymph nodes (lymphadenitis), shortness of breath, and cough. Patients with a paradoxical drug reaction may also experience headaches, loss of appetite, and weight loss.
Uncommon (may affect up to 1 in 100 people)
- Reduction in the number of white blood cells
- Headache, dizziness, fatigue
- Drowsiness, difficulty coordinating movements, difficulty concentrating
- Eye irritation
- Yellowing of the skin (jaundice).
Rare (may affect up to 1 in 1,000 people)
- Kidney failure
- Chills, fever.
Has been reported (occurs in an unknown number of users)
- Low blood pressure
- Elevated renal value (creatinine value)
- Increased accumulation of porphyrins (substances in the liver)
- Blood count changes
- Agranulocytosis (drastic reduction of a type of white blood cell )
- Cerebral hemorrhage and death have been reported when treatment with Rifadin has continued or resumed after the onset of purpura
- Discoloration of tear fluid
- Shortness of breath, wheezing, discolored expectoration
- Stomach pain, disease of the gastrointestinal tract, discoloration of teeth
- Severe renal failure
- Harmless discoloration of the urine
- Itching with or without rash
- Hives and more severe hypersensitivity reactions
- Diverse redness of skin with sweating, high fever
- Discoloration of sweat
- Muscle weakness, muscle disease
- Pain in the skeleton
- Insufficient adrenal function in patients with impaired adrenal function
- Decreased appetite
- Influenza consists of episodes of fever, chills, headache, dizziness
- Vascular wall inflammation
- The insufficient circulating blood volume in the body, can lead to a lack of oxygen in the body’s cells
- Hot flashing
- Fluid retention and swelling
- Chills, fever, hypersensitivity reaction
- Liver inflammation
- Increased level of bilirubin in the blood
- Bile stasis (impaired bile flow)
- Menstrual disorders
- Hallucinations, delusions
- Abnormal bleeding after childbirth
- Transfer of blood from the fetus to the mother’s blood circulation via the placenta.
Decreased platelets, with and without purpura (numerous small hemorrhages in the skin and mucous membranes), may occur, usually with treatment that is interrupted on several different occasions. Platelets return if treatment is stopped as soon as purpura occurs.
How to store Rifadin
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton and label after (EXP. Or 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.
Contents of the package and other information
The active substance is rifampicin 20 mg/ml
The other ingredients are Propylparaben (E 216), methylparaben (E 218), potassium sorbate, saccharin, raspberry essence, sucrose 400 mg/ml, diethanolamine, agar, polysorbate 80, sodium metabisulphite, water.
1 ml contains 0.24 mg of sodium.
What the medicine looks like and the contents of the pack
Glass bottle containing 60 ml suspension.
Marketing Authorisation Holder
Sanofi AB, Box 30052, 104 25 Stockholm