Flexiloges, Film-coated tablets
2 WHAT DOES FLEXILOGES CONTAIN?
The active substance is 480 mg extract (as dry extract) from Harpagophytum procumbensD.C. (devil’s claw) radix, corresponding to 2.1 – 2.4 g root of devil’s claw.
Extractant: ethanol 60% (v / v).
The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, colloidal anhydrous silica, hypromellose, magnesium stearate, talc, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), and brown iron oxide (E172).
4 MARKETING AUTHORIZATION HOLDER
Dr. Loges + Co. GmbH
21423 Winsen (Luhe) Germany
Phone + 49 4171 / 707-0
Fax: + 49 4171 / 707-100
5 WHAT IS FLEXILOGES USED FOR?
Flexiloges is a traditional herbal medicine used to relieve pain in mild joint wear and tear ( osteoarthritis ).
The indications for traditional herbal medicine are based solely on the experience of long-term use.
6 WHEN SHOULD NOT FLEXILOGES BE USED?
Do not use if:
-you are allergic to devil’s claw or any of the other ingredients of this medicine. -if you have previously had or had a stomach ulcer or ulcer on the duodenum.
-if you are pregnant or breastfeeding.
Flexiloges contain lactose . Therefore, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
THINGS TO THINK ABOUT BEFORE AND WHEN FLEXILOGES ARE USED:
If you have gallstone problems or cardiovascular disease, talk to your doctor, pharmacist, or nurse before using Flexiloges.
If your joint pain is accompanied by swelling, severe movement pain, redness, or fever, a doctor should investigate the underlying cause of the pain.
The effect of concomitant use of other drugs has not been studied.
Flexiloges are not recommended for children and adolescents under 18 years of age.
In the absence of adequate data, Flexiloges should not be used by pregnant women.
The safety of the fetus has not been confirmed.
In the absence of adequate data, Flexiloges should not be used by breastfeeding women.
It is not known whether extracts from devil’s claw are transferred to breast milk.
The safety of breast-fed infants has not been confirmed
In rare cases, this product may cause dizziness. If this happens to you, avoid driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or 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 other healthcare professional.
7 HOW TO USE FLEXILOGES
Always use this medicine exactly as described in this leaflet or as directed by your healthcare professional. Ask your doctor or pharmacist if you are unsure.
If you forget to take Flexiloges, do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
INSTRUCTIONS FOR USE
The recommended dose is 1 tablet morning and evening. To be taken with a meal and preferably with a glass of water. The tablets should be swallowed whole.
You should talk to a doctor if symptoms worsen or do not improve within 4 weeks.
WHAT HAPPENS IF YOU TAKE TOO LARGE DOSE?
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
8 WHAT SIDE EFFECTS CAN FLEXILOGES PROVIDE?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Diarrhea, nausea, vomiting, and abdominal pain have been reported as well as dizziness, headache, and allergic skin reactions.
9 HOW TO STORE FLEXILOGES?
Do not use this medicine after the expiry date which is stated on the carton.
Keep out of reach of children.
Leftover or too old medicine can be left at the pharmacy for destruction.
10 WHAT DURABILITY DOES FLEXILOGES HAVE?