Newmed Kohlenhydrat Bl

Organization name

PK Benelux BV

SRN

NL-MF-000006672

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Warnings: • Do not chew or bite the tablets; • Keep out of reach of children; • Do not use if the blister package has been damaged. Restrictions on use: Carb & Fat blocker may be used for periods longer than four weeks if you comply with the following restrictions on use: • Obtain medical advice before long-term use of the product; • Do not take medicinal products (e.g. contraceptives), vitamins or essential fatty acids at the same time as Carb & Fatblocker; Oral medication must be taken 1 hour before or 4 hours after using . Carb & Fatblocker. Consult your doctor before using Carb & Fatblocker if you need to take medication at main meal times; • In the event of constipation or other side effects, you should immediately discontinue use and consult a doctor. Side effects: • No harmful side effects are known, but you may experience a temporary feeling of satiety after taking Carb & Fatblocker. This normally disappears after a short time; • Persons with sensitive stomachs or bowels might experience abdominal discomfort, nausea, stomach upset, indigestion, abdominal pain, gas or constipation. If the side effects continue, the dose should be reduced or intake should be discontinued. Contraindications: Do not take Carb & Fatblocker if: • You are hypersensitive or allergic to one of the ingredients; • You suffer or have suffered from gastrointestinal disorders (e.g. acid reflux disease, gastritis, ventricular or duodenal ulcers, Crohn’s disease, ulcerative colitis, diverticulitis), signs of intestinal obstruction (impending or existing mechanical or paralytic ileus), gastroparesis in diabetics with neuropathy, intestinal polyps or existing severe digestive disorders (constipation); • You are taking Warfarin (blood thinner); • You are underweight (Body Mass Index (BMI)<18.5); • You are pregnant or breastfeeding; • Not suitable for babies or infants; • Children and adolescents should use Carb & Fatblocker only after consulting a doctor.

Primary placement in Netherlands; available across 1 country total.

Trade name

Newmed Kohlenhydrat Bl

UDI-DI code

D-075983QJ

Basic UDI-DI

B-075983QJ

Reference / catalog number

075983

Issuing entity

EUDAMED

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

To reduce the caloric impact and help to treat and prevent obesity and overweight.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• G0402ORALLY ADMINISTERED DEVICES FOR APPETITE CONTROL AND REDUCTION OF INTESTINAL ABSORPTION